The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System – Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery. The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Device Story
Remanufactured robotic surgical instruments (cautery hook and spatula); used with da Vinci X/Xi Surgical Systems. Input: manual control signals from surgeon via robotic console; Output: mechanical tissue manipulation and monopolar electrocautery. Components: housing, shaft, wrist, tip. Operation: instruments provide enhanced dexterity/range of motion for minimally invasive surgery; used by trained physicians in OR. Remanufacturing process restores used instruments to OEM specifications for up to 10 additional clinical cycles via validated inspection, repair, cleaning, and testing. Benefit: extends instrument life while maintaining original performance, safety, and clinical utility.
Clinical Evidence
Bench testing only. Evaluations included biocompatibility (ISO 10993), functional mechanical/electrical performance, cleaning validation (protein, hemoglobin, TOC residue analysis), and electrical safety (IEC 60601-1). No clinical data presented.
Technological Characteristics
Reusable, non-sterile robotic instruments. Components: housing, shaft, wrist, tip. Energy: monopolar electrocautery. Connectivity: mechanical interface with da Vinci X/Xi systems. Standards: ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety).
Indications for Use
Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically assisted cardiotomy procedures, including coronary anastomosis via adjunctive mediastinotomy, requiring tissue dissection and division via monopolar cautery.
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.
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments (K203632)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
March 26, 2026
Restore Robotics
Kevin May
Chief Operating Officer
15 Longevity Dr.
Building C
Henderson, Nevada 89014
Re: K252926
Trade/Device Name: Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: QSM
Dated: February 13, 2026
Received: February 13, 2026
Dear Kevin May:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K252926 - Kevin May
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
{2}
K252926 - Kevin May
Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MARK TRUMBORE -S
Digitally signed by
MARK TRUMBORE -S
Date: 2026.03.26
14:40:15 -04'00"
Mark Trumbore Ph.D.
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
Page 9 of 45
| Indications for Use | |
| --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K252926 |
| Please provide the device trade name(s). | |
| Robotic Surgical Instruments - Permanent Cautery Hook (470183);
Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | |
| Please provide your Indications for Use below. | |
| The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula
(470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System –
Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be
used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with
monopolar cautery.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is
intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid
endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders,
endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including
grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery
and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical
procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures,
general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The
system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during
cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by
trained physicians in an operating room environment in accordance with the representative, specific
procedures set forth in the Professional Instructions for Use. | |
| Please select the types of uses (select one or both, as
applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
{4}
| 510(k) #: K252926 | 510(k) Summary | Prepared on: 2026-02-13 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Restore Robotics | |
| Applicant Address | 15 Longevity Dr. Building C Henderson NV 89014 United States | |
| Applicant Contact Telephone | 678.619.0011 | |
| Applicant Contact | Mr. Kevin May | |
| Applicant Contact Email | kmay@restorerobotics.net | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | |
| Common Name | Robotic Surgical Instruments | |
| Classification Name | Robotic Surgical Instruments | |
| Regulation Number | 21 CFR §876.1500 | |
| Product Code(s) | QSM, NAY | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K131861 | da Vinci X Surgical System | NAY |
| K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments | NAY |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System – Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery. Each instrument consists of four primary components: the housing, shaft, wrist, and tip. The shaft and wrist enable multiple axes of articulation, while the tip is designed for direct interaction with tissue. When operated in conjunction with the appropriate robotic system, these instruments provide enhanced dexterity and a greater range of motion than the human hand, facilitating precise tissue manipulation and dissection in minimally invasive procedures. The remanufactured devices are intended for up to ten (10) additional clinical use cycles beyond the OEM-cleared use life, as supported by validated reprocessing and performance testing. The design, materials, and intended use are identical to the Predicate Device (K131861) in form, fit, and function. The mechanism of action is unchanged and remains based on the same fundamental mechanical architecture and dimensions. There are no changes to: - The indications for use | | |
{5}
- Clinical applications
- Patient population
- Performance specifications
- Method of operation
In accordance with the Design Control process, a comprehensive risk analysis was conducted to evaluate the impact of remanufacturing. The remanufacturing process includes validated inspection, repair, testing, and cleaning procedures to ensure safety and effectiveness. Design verification and validation activities confirmed that the Subject Devices meet all applicable design input requirements. The following evaluations were performed, or rationales were provided where testing was not required, consistent with applicable standards and FDA guidance:
- Biocompatibility (per ISO 10993)
- Functional performance testing (mechanical and electrical)
- Cleaning validation (including protein, hemoglobin, and TOC residue analysis)
- Electrical safety testing (per IEC 60601-1 and relevant clauses)
Test results support that the remanufactured instruments are as safe and effective as the Predicate Devices and meet all required specifications for intended use.
Additionally, FDA-cleared Reference Device (K203632) is cited to support the validated cleaning and reprocessing methods associated with the proposed ten (10) reuse cycles.
## Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System – Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
## Indications for Use Comparison
21 CFR 807.92(a)(5)
The Subject Devices, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), have the same intended use as the Predicate Device (da Vinci X Surgical System, (K131861). Both are intended for use with the da Vinci X/Xi Surgical System – Intuitive Surgical, Inc. These devices are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery.
Although the indications for use statements differ in scope, this reflects only the level of description. The Predicate Device describes the surgical system, while the Subject Devices describe the compatible instruments. These differences do not alter the underlying intended use or raise new questions of safety or effectiveness.
The Subject Devices do not introduce any new clinical applications, anatomical targets, user populations, or surgical modalities. Therefore, consistent with 21 CFR 807.92 and FDA's The S10(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (2014) guidance, these differences in indication wording do not constitute a new or different intended use.
## Technological Comparison
21 CFR 807.92(a)(6)
The Subject Devices, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are identical in design, materials, dimensions, and functional characteristics to the instruments cleared for use with the da Vinci X Surgical System (K131861). Both the
{6}
Predicate and Subject Devices enable endoscopic tissue dissection using monopolar electrocautery.
The remanufacturing process does not introduce any new technological characteristics. It restores previously used instruments to their original form, fit, and function through validated inspection, cleaning, repair, and testing procedures. All mechanical, electrical, and performance attributes remain consistent with those of the Predicate Device.
Accordingly, the Subject Devices have the same intended use and technological characteristics as the Predicate Device, and no new questions of safety or effectiveness are raised. The remanufactured Subject Devices perform equivalently to the Predicate Device cleared under K131861, as demonstrated through design verification, cleaning validation, and functional testing.
# Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
In accordance with the Design Control process, a comprehensive risk analysis was conducted to evaluate the impact of remanufacturing. The remanufacturing process includes validated inspection, repair, testing, and cleaning procedures to ensure safety and effectiveness. Design verification and validation activities confirmed that the Subject Devices meet all applicable design input requirements.
The following evaluations were performed, or rationales were provided where testing was not required, consistent with applicable standards and FDA guidance:
- Biocompatibility (per ISO 10993)
- Functional performance testing (mechanical and electrical)
- Cleaning validation (including protein, hemoglobin, and TOC residue analysis)
- Electrical safety testing (per IEC 60601-1 and relevant clauses)
Test results support that the remanufactured instruments are as safe and effective as the Predicate Device(s) and meet all required specifications for intended use.
Additionally, FDA-cleared Reference Device (K203632) is cited to support the validated cleaning and reprocessing methods associated with the proposed ten (10) reuse cycles.
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.
