K142427 · Applied Medical Resources · GCJ · Dec 23, 2014 · Gastroenterology, Urology
Device Facts
Record ID
K142427
Device Name
TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25
Applicant
Applied Medical Resources
Product Code
GCJ · Gastroenterology, Urology
Decision Date
Dec 23, 2014
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Applied Medical Tissue Containment System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation. The Tissue Containment System is contraindicated for laparoscopic power morcellation during gynecologic procedures. The Tissue Containment System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
Device Story
Flexible tissue bag with attached tether and guard accessory; used to contain/isolate specimens during surgical removal or manual morcellation. Device inserted into abdominal/pelvic cavity; bag mouth returns to circular shape for specimen placement. Tether maneuvers ring to extraction site; ring can be flipped to shorten bag for manual morcellation. Guard placed in bag opening to provide barrier against sharp instruments. Used by surgeons in clinical settings. Benefits include specimen containment and isolation during extraction, reducing risk of tissue spread during manual morcellation.
Clinical Evidence
Bench testing only. Evaluated biocompatibility (cytotoxicity, irritation, sensitization per ISO 10993-1) and mechanical performance (seam integrity, tether break force, puncture resistance). Additional functional testing included dye penetration, viral penetration, bubble leak, and simulated use. No clinical data presented.
Technological Characteristics
Flexible tissue bag with tether and guard. Materials evaluated for biocompatibility per ISO 10993-1. Mechanical features include ring-based opening mechanism and guard barrier. Sterile, single-use device. No electronic or software components.
Indications for Use
Indicated for containment and isolation of tissue during or prior to surgical removal and/or extracorporeal manual morcellation. Contraindicated for laparoscopic power morcellation in gynecologic procedures and for use with powered cutting devices (e.g., power morcellators, electrosurgical, laser instruments).
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.
Predicate Devices
Applied Medical Specimen Retrieval System (K060051)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2014
Applied Medical Resources Corporation Ms. Aeree Lee Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K142427
Trade/Device Name: Applied Medical Tissue Containment System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: November 21, 2014 Received: November 24, 2014
Dear Ms. Lee:
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 FDA'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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K142427
Device Name
Applied Medical Tissue Containment System
#### Indications for Use (Describe)
The Applied Medical Tissue Containment System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.
Contraindications:
The Tissue Containment System is contraindicated for laparoscopic power morcellation during gynecologic procedures.
The Tissue Containment System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the physician, use of such a device would be contrary to the best interest of the patient.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(K) Submitter: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA, 92688<br>(949) 713-8000 | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Contact Person: | Aeree Lee<br>Regulatory Affairs Specialist<br>Applied Medical Resources<br>aelee@appliedmedical.com<br>Tel: (949) 713-8272<br>Fax: (949) 713-8205 | |
| Date of Preparation: | August 28, 2014 | |
| Trade Name: | Applied Medical Tissue Containment System | |
| Common Name: | Tissue Bag | |
| Classification: | Accessory to Endoscope, Class II<br>Product Code: GCJ | Regulation: 21 CFR 876.1500 |
| Predicate Device: | Applied Medical Specimen Retrieval System<br>510(k)#: K060051<br>Product Code: GCJ | Regulation: 21 CFR 876.1500 |
| | Cook LapSac Tissue Entrapment Pouch<br>510(k)#: K910914<br>Product Code: KGY | Regulation: 21 CFR 878.4100 |
| Device Description: | The Applied Medical Tissue Containment System is a flexible<br>tissue bag that includes an attached tether and guard accessory.<br>The subject system is provided sterile.<br>The Tissue Containment System is used to contain and isolate<br>specimens for surgical removal and/or manual morcellation.<br>After the device is fully inserted into the abdominal or pelvic<br>cavity, the mouth of the bag returns to its original, circular shape,<br>facilitating placement of the specimen in the bag. When the<br>specimen is ready for removal and/or manual morcellation, the<br>tether is used to maneuver the ring to the surface of the | |
| | If the specimen requires manual morcellation, the ring may be<br>repeatedly flipped to shorten the bag and consequently bring the<br>specimen closer to the extraction site. The guard is placed in the<br>bag opening prior to manual morcellation, providing a robust<br>barrier between the bag and sharp instruments. | |
| Intended Use: | The Applied Medical Tissue Containment System is indicated to<br>contain and isolate tissue during, or prior to, surgical removal<br>and/or extracorporeal manual morcellation. | |
| | The Tissue Containment System is contraindicated for laparoscopic<br>power morcellation during gynecologic procedures. | |
| | The Tissue Containment System is contraindicated for use with<br>powered cutting devices (e.g., power morcellators, electrosurgical<br>and laser instruments), and when, in the judgment of the physician,<br>use of such a device would be contrary to the best interest of the<br>patient. | |
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extraction site.
## Comparison of Technological Characteristics with the Predicate Device:
The subject and predicate devices are both tissue bags intended to retrieve and contain specimens during manual morcellation. Both devices are wholly inserted into the abdominal or pelvic cavity prior to specimen placement in the bag. If the specimen requires morcellation, both bags are brought up to the extraction site prior to morcellation.
The following technological differences exist between the subject and predicate devices:
- Mechanism of the bag opening
- o Use of different materials
- 0 Addition of a guard in subject device
### Discussion of Performance Testing:
The following performance data is provided in support of the substantial equivalence determination.
### Biocompatibility
The biocompatibility evaluation for the Applied Medical Tissue Containment System was conducted in accordance with the FDA G95-1 Blue Book Memo, the FDA Draft Guidance "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing''', and the International Standard ISO 10993-1. The subject
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device is a device that contacts tissue for a duration of less than 24 hours and the following tests were considered:
- Cytotoxicity
- Irritation ●
- o Sensitization
All materials were found to be biocompatible.
#### Mechanical Testing
Side-by-side bench top testing was performed with the subject and predicate devices to demonstrate substantial equivalence. The bench top tests were designed to focus on the functional performance of the specimen containment and retrieval features, as well as its use during morcellation. Both subject and predicate devices were evaluated for:
- Bag seam integrity
- o Tether break force
- o Puncture resistance
Additional testing was performed on the subject device to evaluate the device functionality:
- Dye penetration
- Viral penetration
- Bubble leak ●
- o Simulated use
### Conclusions:
Results of testing demonstrates that the subject Tissue Containment System is substantially equivalent to the predicates Applied Medical Specimen Retrieval System and Cook LapSac Tissue Entrapment Pouch, and that the subject device performs comparably to the current marketed device for the same intended use.
