Published clinical literature (Cadiere et al., 2008; Von Renteln et al., 2008)
The sponsor utilized published clinical data from studies of predicate devices (EsophyX and Plicator) to compare the safety and efficacy outcomes (GERD-HRQL scores and pH monitoring) of the SRS system against established clinical benchmarks.
Literature review; Comparative effectiveness; GERD; Predicate device performance
Von Renteln et al. (2008) - Plicator multicenter study; Multicenter study
Patients with GERD; Number of Sites: Multicenter
Not applicable for this study
GERD-HRQL score, pH < 4.0 exposure
Indications for Use
The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease (GERD) in patients who require and respond to pharmacological therapy.
Device Story
SRS Endoscopic Stapling System creates anterior partial fundoplication to treat GERD. System includes flexible endoscope with integrated video camera, ultrasound range-finder, and stapler mechanism; ISL (Insufflation, Suction, Light) console; and Camera Control Unit (CCU). Physician operates device endoluminally, using ultrasound for precise positioning of anvil and cartridge against stomach fundus and esophagus. Mechanical trigger/knob launches titanium staples to secure tissue fold, creating valve to prevent gastric acid reflux. Procedure performed in clinical setting. Output is visual endoscopic feed and ultrasound data for guidance. Benefits include minimally invasive alternative to traditional surgery for GERD symptom management.
Clinical Evidence
Clinical evidence includes a feasibility study (n=6), pilot study (n=13), and pivotal prospective multi-site study (n=72). Primary endpoint: >50% improvement in GERD-HRQL score off PPI at 6 months. Results: 75% of patients met primary endpoint; median GERD-HRQL score improved 79.3%. Secondary endpoint (acid exposure, pH < 4.0) showed 19% reduction. Safety profile comparable to predicates; SAEs included esophageal perforation, pneumothorax, and pneumoperitoneum. Bench testing included biocompatibility (ISO 10993), electrical safety (IEC 60601-1), and mechanical/acoustic testing.
Technological Characteristics
Flexible endoscope with video camera, ultrasound range-finder, and stapler mechanism. Components: ISL console, CCU, irrigation/suction accessories, overtube. Titanium staples. Energy: electrical (consoles). Connectivity: wired system components. Sterilization: not specified. Principle: mechanical stapling of soft tissue under visual/ultrasound guidance.
Indications for Use
Indicated for patients with symptomatic chronic GERD who require and respond to pharmacological therapy. Used for endoscopic placement of surgical staples in esophageal and stomach soft tissue to create anterior partial fundoplication.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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# MAY 1 8 2012
#### 510(k) SUMMARY
# Medigus' SRS Endoscopic Stapling System
#### l. SUBMITTER
Medigus Ltd. 7A Industrial Park, P.O. Box 3030 Omer 84965, Israel
Phone: +972-8-6466770 Facsimile: +972-8-6466770
Contact Person: Jon Griver Date Prepared: May 16, 2012
#### II. DEVICE
#### Name of Device and Name/Address of Sponsor
- Medigus Ltd. 7 A Industrial Park, P.O. Box 3030 Omer 84965, lsrael
#### Common or Usual Name
SRS Endoscopic Stapling System (abbreviated in this document to 'SRS')
#### Classification Name
Endoscope and Accessories (21 CFR §876.1500)
Regulatory Class: ll
Product Code: ODE
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# Predicate Devices
Endoscopic Plication System, also referred to as Plicator™, manufactured by NDO Surgical Inc. of Mansfield, Massachusetts, cleared under 510(k) #K023234, #K031262 and #K071553.
EsophyX System with EGS SerosaFuse™, manufactured by EndoGastric Solutions Inc. of Redmond, Washington and cleared under 510(k) # K071651.
# Intended Use / Indications for Use
The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease (GERD) in patients who require and respond to pharmacological therapy.
# Technological Characteristics
The Medigus SRS is an Endoscopic Stapling System. The device consists of the following components and accessories:
- . The flexible endoscope combines a video camera, ultrasound sensor (range finder) and a stapler mechanism. The distal end of the endoscope is capable of retroflexion. The system enables creation of an endoluminally anterior partial fundoplication by stapling together the soft tissue of the fundus (upper part of the stomach) and the esophagus.
- The endoscopy suite includes the ISL (Insufflation, Suction and Light) console and the CCU . (Camera Control Unit) console.
- The associated accessories include: .
- Irrigation bottle with liquids for irrigation of the camera lens l
- Suction canister for extracting liquids during the procedure .
- . Silicon tubes for connecting the ISL and other accessories to the endoscope
- . Disposable air filter of the suction ISL input channel
- I Overtube for protecting patient's pharynx
# Comparison of Technological Characteristics with Predicate Devices
The candidate device and both predicate devices are based on the same technological elements:
- l Endoscope - used to reach the target tissue
- I Device inserted through an overtube - to protect the esophagus
- . Creation of a gastric (or gastroesophageal) plication in close proximity to the gastroesophageal junction - either by the retroflexed device (SRS and EsophyX) or by a retractor (Plicator)
- l Use of a permanent implant made of titanium (SRS, EPS) or polypropylene (EsophX)
- Delivery of the elements needed to complete the procedure through the endoscopic device
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- Visual control of the device's position and orientation before releasing the implant; an ■ ultrasound range-finder provides added positioning accuracy for the SRS system
- l Use of a mechanical component for positioning and launching the implant: a stylet (EPS, EsophyX) or positioning screws (SRS)
- . User-controlled mechanical trigger (or knob) to launch the fastener (implant)
- . Mechanically securing the plication by a permanent implant fastener (SRS and EsophyX) or a sutured bridge (EPS)
The candidate and predicate devices have the same principle of operation, using a device-delivered, permanent implant to secure a plication, intended to create an anatomical fold that will serve as a valve close to the gastroesophageal junction, thereby preventing flow of gastric contents into the esophagus. The unique aspects of SRS are intended to improve the precision of positioning the anvil and cartridge (ultrasound range finder) and the use of staples as fasteners.
The use of staples for permanently attaching soft tissues is a well-established surgical technique. The specific staple used in the SRS System is substantially equivalent to the Auto Suture Surgical Staples manufactured by United States Surgical of Norwalk, Connecticut and cleared by FDA under 510(k) #K013860 on December 19, 2001.
Neither element represents a significant change in the principle of operation or the technological manifestation of the device, and therefore the candidate device is substantially equivalent to the predicate devices in its technological features.
# Performance Data
The following performance data was provided in substantial equivalence determination.
## Biocompatibility testing
The biocompatibility evaluation program for the SRS System was based on demonstrating compliance with FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." The testing program included cytotoxicity, sensitization, irritation, and pyrogenicity.
#### Electrical safety and electromagnetic compatibility
Electrical safety and electromagnetic compatibility (EMC) testing was conducted on the SRS System, consisting of the ISL console, the CCU console and endoscope. The system complies with the IEC 60601-1, IEC 60601-2-18 and IEC 60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC,
#### Mechanical and acoustic testing
Following a detailed risk analysis, a series of mechanical tests concerning the manual operation of the system and its mechanical performance were formulated. The system successfully passed all The acoustic transducer included in the system was tested to its the mechanical tests. specifications.
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### Animal testing
In the course of the development of the device, Medigus conducted numerous tests with prototype devices on a porcine model. These included survival and non-survival studies, as well as staple longevity for up to 13 months.
All of these experiments were carried out at the Animal Research facility of the Institute for Animal Research, Lahav, Israel, and were authorized, according to the Israeli animal welfare act, by the institutional review board for animal research of the health sciences of Ben-Gurion University of the Negev, Beer Sheva, Israel.
The main animal study was performed in conformity with GLP standards by an external subcontractor (ECON AG Mecklenbureger str. 233 D-23568 Lubeck, Germany). The experiments were conducted at the animal research facilities of the Virchow Institute in Berlin, Germany. The complete study report was submitted in the original IDE (G070138).
In the GLP animal study, 16 pigs underwent endoscopy with the SRS System. Twelve pigs underwent fundoplication, and 4 pigs served as a sham (control) group. There were no procedure related complications or mortality in this study, at 2, 4 and 6 weeks follow-up (4 in pigs in each group).
The safety and feasibility of the Medigus SRS device were evaluated by macroscopic and histological evaluation of the tissue in the treatment stapled areas.
These studies demonstrated that the Medigus SRS® device can safely create an anterior partial fundoplication, equivalent to that which is constructed using conventional laparoscopic or open surgical techniques.
### Clinical testing
Clinical testing of the device included an initial feasibility study of 6 patients, a pilot study consisting of 13 patients and a pivotal study of 72 patients.
#### Pilot Study
All pilot-study patients were treated with the SRS and recovered from the procedure without sequelae. There was one anticipated procedure related adverse event, benign pneumoperitoneum, which resolved spontaneously within 48 hours.
The main success criterion of the pilot study, improvement in GERD HRQL score by 50% or more at six weeks post-procedure, was met by 12 of the 13 subjects, and was very close to 50% (48.3%) in the thirteenth patient. All subjects reduced their PPI use. Twelve of the subjects were off daily PPI and met the secondary success criterion (reduction to < 50%). Eight subjects were off any GERD related medications.
The pilot study suggested that the SRS is comparable to other endoscopic procedures or laparoscopic surgery procedures in terms of safety and effectiveness.
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#### Pivotal Study
In the pivotal study of 72 patients, following the surgical procedure performed by the SRS Endoscopic Stapling System, patients were followed for a period of six months.
#### Safety
The SRS study reported ten patients with a total of ten serious adverse events. Four events were considered 'mild' in intensity, involving pain and fever. Three events were classified as 'moderate' in intensity, involving pneumothorax, pneumomediastinum, pneumoperitoneum (all resolved spontaneously). Two events were considered 'severe' in intensity: one involved esophageal perforation (required drainage) and another had suicidal thoughts (non-device/procedure related). The intensity of one SAE that involved GI bleeding and required a transfusion, was not classified. Six of the SAEs were considered related to the device - one definitely (esophageal perforation) and the others possibly. Three events were considered not related to the device. The median time from procedure to SAE was 1.5 days for events related to the device. None of the patients with SAEs required any operation or re-operation.
Adverse events reported in the SRS that occurred in greater that 5% level were postoperative pain or discomfort in 33%, postoperative nausea in approximately 10%, and sore throat in 21%. The adverse events were mild or insignificant in most cases.
The SAE and overall safety profile were similar to the Esophyx predicate device for which two perforations and one bleeding were reported.
The number of AEs was similar to those reported for the EsophyX and Plicator: Three cases of fever were reported in the current study (for 72 patients), similar to the 3 cases of fever reported for EsophyX. There were 23 cases of chest pain (23/72 = 32%) vs. 17% reported for Plicator; whereas abdominal pain was recorded for 44% of the patients for Plicator and 15% of the patients that underwent EsophyX treatment. Sore throat was reported for 15 patients (15/72 = 21%) vs. 15% for Plicator and 8% for EsophyX also reported 7% of nausea events and 4% of dysphaqia, whereas there were no reports of dysphagia in the current study and only 7 (7/72 = 10%) reports of nausea (there were also two reports of vomiting).
In summary, the adverse events and serious adverse events recorded in the study were similar in nature and frequency to those reported for the predicate endoscopic fundoplication systems. Therefore the clinical results reported for this study documented the safety and effectiveness of the SRS system for its intended use.
#### Efficacy
The primary endpoint for the SRS study focused on the GERD-HRQL score. The study results show that 75% of the patients had a >50% improvement in their GERD-HRQL score off PPI at six months compared to baseline. Hence the study met its primary endpoint with the required 95% confidence level.
The reduction in the median score for the SRS of 23.0 units (from 29.0 to 6.0) represents a 79.3% improvement. This value is almost identical to the result reported by Cadiere et al (1) for the pivotal trial of the EsophyX system (79.2%), and slightly better than the result reported by Von Renteln et al
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(2) for the NDO Plicator (76.0%). Therefore, the efficacy of the SRS system in successfully treating chronic symptoms of GERD is similar to the efficacy reported by both predicate devices.
The median value of the percent of time pH < 4.0 decreased from an initial value of 8.3% at baseline to 6.75%. Therefore, the study met its secondary endpoint related to the acid exposure test. A comparison to similar results reported in the literature revealed that the change in the median values for the EsophyX system (1) showed a decrease of 31%, a decrease of 18% for the Plicator (2) with a corresponding decrease of 19% for the SRS system. Hence, the SRS results in reducing the exposure to gastric acids are similar to those reported for the Plicator system and are lower than those reported for the EsophyX system.
In summary, based on the clinical performance as documented in the prospective, multi-site clinical trial, the SRS system was found to have a safety and efficacy profile that are substantially equivalent to those of the predicate devices.
# Substantial Equivalence
The SRS is as safe and effective as the predicate devices - Endoscopic Plication System (and Plicator) by NDO Surgical Inc. and the EsophyX System with EGS SerosaFuse by the EndoGastric The SRS has the same intended uses and similar indications, technological Solutions Inc. characteristics, and principles of operation as its predicate devices. The minor technological differences between the SRS and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the SRS is as safe and effective as the Endoscopic Plication System and the EsophyX System with EGS SerosaFuse. Thus, the SRS is substantially equivalent.
#### REFERENCES
- 1. Cadière GB, Buset M, Muls V, Rajan A, Rösch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA and Devière J. Antireflux Transoral Incisionless Fundoplication Using EsophyX: 12-Month Results of a Prospective Multicenter Study. World Journal of Surgery (2008) 32:1676-1688.
- 2. Von Renteln D, Schiefke I, Fuchs KH, Raczynski S, Philipper M, Breithaupt, W, Caca K and Neuhaus H. Endoscopic full-thickness plication for the treatment of GERD by application of multiple Plicator implants: a multicenter study. Gastrointestinal Endoscopy (2008). 68(5):833-844.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is rendered in black and white.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medigus, Ltd. % Mr. Jonathan S. Kahan Regulatory Counsel Hogan Lovells US LLP Columbia Square 555 13th Street. NW WASHINGTON DC 20004
# MAY 1 8 2012
K120299 Re:
> Trade/Device Name: SRS Endoscopic Stapling System Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODE Dated: May 1, 2012 Received: May 1, 2012
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FD'A's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Eubanks
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use Statement
510(k) Number (if known):
Device Name:
SRS Endoscopic Stapling System
K120299
Indications for Use:
The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amm In Wly
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ K120299
Page 1 of 1
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
