The EndoWrist Long Tip Forceps instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System and the Intuitive Surgical IS3000 da Vinci Si Surgical System for grasping and manipulation of tissue.

The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection 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 (except for transoral otolaryngology surgical procedures). 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 Description

The subject device is a remanufactured 420048 Long Tip Forceps with a grasping end effector to be used with the Intuitive Surgical da Vinci Endoscopic Instrument Control System (IS 2000 / IS 3000) for grasping and manipulating tissue during an endoscopic procedure. The mechanism of action and principles of operation for the subject device are identical to the predicate device, as there has been no modification to the mechanical design, materials, or dimensions. There are no changes to the claims, intended use, clinical applications, patient population, or method of operation.

AI/ML Overview

The provided FDA 510(k) clearance letter for the Remanufactured EndoWrist Long Tip Forceps (K250387) primarily focuses on establishing substantial equivalence to a predicate device. This type of submission often relies more on non-clinical performance data and a comparison to an existing device rather than a comprehensive de novo clinical study with pre-defined acceptance criteria for an AI/CADe device.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/CADe devices (items 1-9) does not directly apply to this remanufactured medical instrument. The "study" described in this document is a non-clinical performance evaluation aiming to demonstrate that the remanufactured device performs equivalently to the original and does not introduce new safety or efficacy concerns.

However, I can interpret the available information to best fit the prompt's structure, focusing on the concepts of "acceptance" and "proof" as presented in this 510(k).

Here's an analysis based on the provided text, rephrasing where necessary to align with the spirit of the prompt's questions, while acknowledging the inherent differences for a remanufactured mechanical device vs. a typical AI/CADe submission:

Understanding "Acceptance Criteria" for a Remanufactured Medical Device

For a remanufactured device like the EndoWrist Long Tip Forceps, "acceptance criteria" are not typically expressed as sensitivity/specificity thresholds for diagnostic accuracy (as would be the case for AI). Instead, they are related to functional equivalence, safety, and durability compared to the original device. The "study" proving acceptance is a set of non-clinical tests and assessments demonstrating that the remanufactured device meets these criteria and poses no new risks.

The "Study" Proving Acceptance

The submission describes a comprehensive non-clinical performance evaluation rather than a human-in-the-loop clinical trial or a standalone algorithm performance study. The core of the "proof" revolves around showing that the remanufactured device maintains the same performance, safety, and durability characteristics as the original, legally marketed predicate device.

Detailed Information Based on the Provided Document:

1. Table of "Acceptance Criteria" (Interpreted) and Reported Device Performance:

Acceptance Criteria (Interpreted for Remanufactured Device)	Reported Device Performance (Summary from Text)
Functional Equivalence: Mechanism of action and principles of operation are identical to the predicate device.	"The mechanism of action and principles of operation for the subject device are identical to the predicate device, as there has been no modification to the mechanical design, materials, or dimensions." "The remanufactured Long Tip Forceps have the same technological characteristics including design, material, chemical composition, principle of operation, energy source, performance, and host system compatibility as the predicate OEM device."
Durability / Life Extension: Ability to withstand additional controlled uses without performance degradation.	"Life testing to verify device performance and durability through additional uses" was performed. The "use counter has been reset to permit an additional controlled set of uses." (Implies successful completion of this testing).
Electrical Safety: Compliance with relevant electrical safety standards.	"Electrical safety evaluation (per IEC 60601-1)" was performed. (Implies compliance).
Biocompatibility: No adverse biological reactions.	"Biocompatibility testing (per ISO 10993-1)" was performed. (Implies compliance).
Reprocessing Validation: Ability to be reprocessed effectively per OEM instructions.	"Reprocessing validation (per OEM instructions)" was performed. (Implies successful validation).
Cybersecurity: Assessment of cybersecurity risks (if applicable to device control system).	"Cybersecurity assessment (per FDA Guidance on Cybersecurity in Medical Devices)" was performed. (Implies identified risks were addressed, though the forceps alone are unlikely to have complex cybersecurity needs, it's tied to the control system).
No New Safety/Efficacy Questions: Demonstration that remanufacturing does not introduce new concerns.	"Based on the detailed comparison of Indications for Use, Technological Characteristics, and Performance Characteristics, it can be concluded that the proposed Remanufactured Long Tip Forceps is demonstrated to be substantially equivalent to the predicate devices, with no different questions of safety or efficacy having been raised."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated as a number of devices (e.g., N=X remanufactured forceps were tested). Instead, the submission describes types of tests (life testing, electrical safety, biocompatibility, reprocessing validation, cybersecurity assessment) applied to the remanufactured device. It's implied that sufficient samples were tested to gain confidence in the established equivalence.
Data Provenance: The data are non-clinical engineering and laboratory test results generated by the manufacturer (Rebotix) and/or their testing partners. The country of origin of the data is not specified, but the applicant and correspondent are US-based. This is neither retrospective nor prospective in the clinical sense, but rather lab-based validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This question is not applicable in the traditional sense for a remanufactured mechanical instrument. "Ground truth" for an AI/CADe system is typically expert-labeled data.
For this device, the "ground truth" for performance and safety is defined by the specifications and performance of the original, new predicate device. The "experts" involved would be the engineers, quality control personnel, and regulatory specialists who designed and executed the non-clinical tests and analyzed the results against established engineering standards and the predicate's performance. Their qualifications would be in engineering, materials science, electrical safety, biocompatibility, and quality assurance. Their exact number and specific qualifications are not detailed in this clearance letter.

4. Adjudication Method for the Test Set:

Not applicable in the context of human reader consensus for AI performance.
For mechanical testing, validation would involve comparison against predefined engineering specifications and performance benchmarks of the original device and relevant standards (e.g., IEC, ISO). Any deviations would likely be evaluated by a multidisciplinary team (engineering, quality, regulatory) within the manufacturer.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was NOT done. This type of study is specifically designed to assess the impact of AI assistance on human reader performance, which is not relevant for a remanufactured surgical instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was NOT done. This device is a mechanical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" is established through objective, measurable engineering parameters and performance characteristics of the predicate (original) device, as well as relevant international standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601-1 for electrical safety). It also includes adherence to the "Professional Instructions for Use" for the system it integrates with.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/ML device. The remanufacturing process is a defined mechanical and chemical procedure, not an iterative learning process.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

FDA 510(k) Clearance Letter - K250387

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 19, 2025

Rebotix
℅ Alexsis Torres
Quality and Regulatory Associate
AJW Technology Consultants, Inc.
11705 Boyette Rd #503
Riverview, Florida 33569

Re: K250387
Trade/Device Name: Remanufactured EndoWrist Long Tip Forceps (420048)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: QSM, NAY
Dated: July 22, 2025
Received: July 22, 2025

Dear Alexsis Torres:

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.

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K250387 - Alexsis Torres 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 systems (QS) regulation (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-

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K250387 - Alexsis Torres 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, 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

Digitally signed by Mark Trumbore -S
Date: 2025.08.19 10:48:07 -04'00'

Enclosure

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Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Submission Number (if known): K250387

Device Name: Remanufactured EndoWrist Long Tip Forceps (420048)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary

510(k) #: K250387
Prepared on: 2025-08-15

Contact Details

21 CFR 807.92(a)(1)

Field	Value
Applicant Name	Rebotix
Applicant Address	539 Pasadena Avenue South St. Petersburg FL 33707 United States
Applicant Contact Telephone	727-343-5503
Applicant Contact	Chris Gibson
Applicant Contact Email	Chris@rebotixrepair.com
Correspondent Name	AJW Technology Consultants, Inc.
Correspondent Address	11705 Boyette Rd #503 Riverview FL 33569 United States
Correspondent Contact Telephone	813-645-2855
Correspondent Contact	Ms. Alexsis Torres
Correspondent Contact Email	atorres@ajwtech.com

Device Name

21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	Remanufactured EndoWrist Long Tip Forceps (420048)
Common Name	Endoscope and accessories
Classification Name	System, Surgical, Computer Controlled Instrument, Remanufactured
Regulation Number	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
K203632	420048 Long Tip Forceps	NAY
K081137	420048 Long Tip Forceps	NAY
K050369	420048 Long Tip Forceps	NAY

Device Description Summary

21 CFR 807.92(a)(4)

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modification to the mechanical design, materials, or dimensions. There are no changes to the claims, intended use, clinical applications, patient population, or method of operation.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications for use of the remanufactured Long Tip Forceps is the same as the predicate OEM device.

Technological Comparison

21 CFR 807.92(a)(6)

The remanufactured Long Tip Forceps have the same technological characteristics including design, material, chemical composition, principle of operation, energy source, performance, and host system compatibility as the predicate OEM device. The use counter has been reset to permit an additional controlled set of uses.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

The Remanufactured Long Tip Forceps have the same intended use and technological characteristics as the predicate OEM Long Tip Forceps. An assessment of hazards that could potentially be introduced by the life extension of the Long Tip Forceps was performed, along with a risk analysis of the remanufacturing process. Actions taken to address identified risks included life testing to verify device performance and durability through additional uses, electrical safety evaluation (per IEC 60601-1), biocompatibility testing (per ISO 10993-1), reprocessing validation (per OEM instructions), and cybersecurity assessment (per FDA Guidance on Cybersecurity in Medical Devices). The remanufactured EndoWrist ProGrasp Forceps (model: 420093, K241872) was used as a reference for the testing methods.

Based on the detailed comparison of Indications for Use, Technological Characteristics, and Performance Characteristics, it can be concluded that the proposed Remanufactured Long Tip Forceps is demonstrated to be substantially equivalent to the predicate devices, with no different questions of safety or efficacy having been raised.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.