(133 days)
Not Found
No
The document describes a remanufactured surgical instrument (forceps) and its intended use with a robotic surgical system. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the mechanical function and safety of the remanufactured instrument.
No
The device is a remanufactured surgical instrument (forceps) used for grasping and manipulating tissue during endoscopic procedures, which classifies it as a surgical tool
rather than a therapeutic device in itself.
No
The device description and intended use clearly state its purpose is for grasping and manipulating tissue during surgical procedures, not for diagnosing conditions.
No
The device description explicitly states it is a "remanufactured 420093 ProGrasp Forceps with a grasping end effector," which is a physical instrument used in surgery. The summary also mentions mechanical design, materials, dimensions, and performance studies involving life testing and electrical safety, all indicative of a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "grasping and manipulation of tissue" during surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description reinforces its function as a surgical instrument with a "grasping end effector."
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used directly on tissue within the body.
N/A
Intended Use / Indications for Use
The EndoWrist ProGrasp 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, 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 pediatic 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.
Product codes (comma separated list FDA assigned to the subject device)
OSM, NAY
Device Description
The subject device is a remanufactured 420093 ProGrasp 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 and 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, dinical applications. patient population, or method of operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatic use (except for transoral otolaryngology surgical procedures)
Intended User / Care Setting
trained physicians in an operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Remanufactured ProGrasp Forceps have the same intended use and technological characteristics as the predicate OEM ProGrasp Forceps. An assessment of hazards that could potentially be introduced by the life extension of the ProGrasp 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).
Based on the detailed comparison of Indications for Use, Technological Characteristics, and Performance Characteristics, it can be concluded that the proposed Remanufactured ProGrasp is demonstrated to be substantially equivalent to the predicate devices. with no different questions of safety or efficacy having been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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November 7, 2024
Rebotix % Ryan Burke Consulting Director AJW Technology Consultants, Inc. 11705 Boyette Rd #503 Riverview, Florida 33569
Re: K241872
Trade/Device Name: Remanufactured EndoWrist ProGrasp Forceps (420093) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OSM Dated: October 11, 2024 Received: October 11, 2024
Dear Ryan Burke:
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.
1
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 (OS) 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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatory
2
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,
Image /page/2/Picture/3 description: The image shows the name "Mark Trumbore -S" in a large font on the left side. On the right side, it says "Digitally signed by Mark Trumbore -S". Below that, it shows the date and time as "Date: 2024.11.07 09:20:27 -05'00'".
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
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Indications for Use
510(k) Number (if known) K241872
Device Name
Remanufactured EndoWrist ProGrasp Forceps (420093)
Indications for Use (Describe)
The EndoWrist ProGrasp 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, 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 pediatic 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.
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) |
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510(k) #: K241872
510(k) Summary
Prepared on: 2024-10-11
Contact Details
21 CFR 807.92(a)(1)
| 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 | Mr. Ryan Burke |
| Correspondent Contact Email | rburke@ajwtech.com |
| Device Name | |
| 21 CFR 807.92(a)(2) | |
| Device Trade Name | Remanufactured EndoWrist ProGrasp Forceps (420093) |
| 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 | 420093 ProGrasp Forceps |
| NAY | |
| K081137 | 420093 ProGrasp Forceps |
| NAY | |
| K050369 | 420093 ProGrasp Forceps |
| NAY | |
| Device Description Summary | |
| 21 CFR 807.92(a)(4) |
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The subject device is a remanufactured 420093 ProGrasp 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 and 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, dinical applications. patient population, or method of operation.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The EndoWrist ProGrasp Forceps instrument is used with the Intuitive 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, 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, liectrocautery, 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 orocedures 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 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 sicians in an operating room environment in accordance with the repesentative, specific procedures set forth in the Professional Instructions for Use.
Indications for Use Comparison
The indications for use of the remanufactured ProGrasp Forceps is the same as the predicate OEM device.
Technological Comparison
The remanufactured ProGrasp Forceps have technological characteristics including design, material, chemical composition, principle of operation, energy source, 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 ProGrasp Forceps have the same intended use and technological characteristics as the predicate OEM ProGrasp Forceps. An assessment of hazards that could potentially be introduced by the life extension of the ProGrasp 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).
Based on the detailed comparison of Indications for Use, Technological Characteristics, and Performance Characteristics, it can be concluded that the proposed Remanufactured ProGrasp is demonstrated to be substantially equivalent to the predicate devices. with no different questions of safety or efficacy having been raised.
21 CFR 807.92(a)(5)