(78 days)
The Endolink™ True Movement System™ is intended for grasping, mobilization, dissection and transaction of tissue under direct and endoscopic visualization.
The Endolink™ True Movement System™ (Endolink Instruments) are single use, sterile instruments that consist of a handle, jaws, and a shaft which includes distal and proximal articulating sections. The Endolink Instruments are similar in size to other instruments and are designed for use through an incision or appropriately sized surgical trocars/ports. The instrument jaws (or scissors blades) are opened and closed by compressing and releasing the handle. The handle can include a ratchet and ratchet release which allow the instrument jaws to be locked in place.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices in grasping, manipulating, cutting, and suturing of tissue. | "results showed the Endolink Instruments were equivalent to the predicate device." |
| Conformance to product specifications. | "Product testing was conducted to evaluate conformance to product specifications." |
| Equivalence in general use, basic overall function, manufacturing methods, and materials. | "The Endolink Instruments are equivalent to the predicate products. The general use, basic overall function, methods of manufacturing, and materials used are substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Product testing" and "Testing comparing the Endolink Instruments to a commercially available predicate product."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The comparative testing appears to be primarily performance-based (grasping, manipulating, cutting, suturing) against a predicate device, rather than requiring expert-annotated ground truth in the traditional sense.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. The study described is a comparison against a predicate device, not a human reader study requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The study described focuses on direct device equivalence to a predicate, not on how human readers improve with AI assistance.
6. Standalone Performance Study
Yes, a form of standalone performance study was conducted. The document states:
- "Product testing was conducted to evaluate conformance to product specifications."
- "Testing comparing the Endolink Instruments to a commercially available predicate product was conducted."
- "results showed the Endolink Instruments were equivalent to the predicate device."
While not a typical "AI standalone performance study," these statements indicate the device's functional performance was evaluated independently and in comparison to a benchmark.
7. Type of Ground Truth Used
The "ground truth" in this context appears to be the performance and characteristics of the predicate device. The Endolink True Movement System™ was evaluated for its ability to match the functional capabilities and material properties of existing, legally marketed devices. This is a form of comparative ground truth rather than a clinical ground truth like pathology or expert consensus on a diagnosis.
8. Sample Size for the Training Set
The document does not mention any training set. This is not an AI/ML device in the modern sense; it's a surgical instrument. Therefore, there's no "training set" as would be relevant for machine learning models.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for this device.
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MAR 1 0 2005
510(k) Summary
General Information
| Classification | Class I |
|---|---|
| Trade Name | Endolink TM True Movement System TM |
| Submitter | Novare Surgical Systems, Inc.10440 Bubb RoadSuite ACupertino, CA 95014Tel: 408-873-3161 |
Kerry Pope Contact President & CEO
Intended Use
The Endolink™ True Movement System™ is intended for grasping, mobilization, dissection and transaction of tissue under direct and endoscopic visualization.
Predicate Devices
| K984240 | Endopath Endoscopic InstrumentsEthicon Endo-Surgical, Inc. |
|---|---|
| K972510 | Pivotal Grasper / Dissector / ScissorsImagyn Surgical |
Device Description
The Endolink™ True Movement System™ (Endolink Instruments) are single use, sterile instruments that consist of a handle, jaws, and a shaft which includes distal and proximal articulating sections. The Endolink
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Instruments are similar in size to other instruments and are designed for Instruments are simmal in oize to oursely sized surgical trocars/ports.
use through an incision or appropriately sized surgessing and use through an meision or appropriated by compressing and The instrument jaws (of selssof blace) an include a ratchet and ratchet
releasing the handle. The handle can included in place releasing the 'nandie'.
release which allow the instrument jaws to be locked in place.
Materials
All materials used in the manufacture of the Endolink Instruments are All materials used in the manufacture on our erous previously cleared products.
Testing
Product testing was conducted to evaluate conformance to product Product testing was conducted grasping, manipulating, cutting and suturing of tissue.
Testing comparing the Endolink Instruments to a commercially available resulig comparing the Endominian were used per their predicate product was consults showed the Endolink Instruments were equivalent to the predicate device.
Summary of Substantial Equivalence
The Endolink Instruments are equivalent to the predicate products. The The Endomin frior use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white emblem. The emblem is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the emblem is a stylized image of an eagle.
MAR 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Novare Surgical Systems, Inc. c/o Mr. Gregory Mathison Regulatory Strategies, Inc. 3924 Cascade Beach Road Lutsen, Minnesota 55612
Re: K043541
Ko43541
Trade/Device Name: Endolink™ True Movement System™ Regulation Number: 21 CFR 876.1500 Regulation Name: Laparoscope and accessories Regulatory Class: II Product Code: GCJ Dated: December 20, 2004 Received: December 22, 2004
Dear Mr. Mathison:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and have december and marketed predicate devices marketed in interstate for use stated in the enerosale) to tegains and the Medical Device Amendments, or 10 commerce provision to May 20, 1978, the one with the provisions of the Federal Food, Divig, devices mat have been recuire approval of a premarket approval application (PMA). and Costience Act (71ct) that do not require apt to the general controls provisions of the Act. The 1 ou may, merelore, manel of the Act include requirements for annual registration, listing of general condols provisioning practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassified (boo a croy ols. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition. FDA may be found in the over ments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I heast be advised that i Dri irrosaantes arour device complies with other requirements of the Act that I LTT has made a and regulations administered by other Federal agencies. You must of any I cactar statures and regarants ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY an 6077, laboring (21 OFF Part 820); and if applicable, the electronic form in the quant) bywellar (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Gregory Mathison
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the supply of allers of select of the privalence of your device t This letter will allow you to begin halkting of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equires of your de premarket notification. The PDA midnig of substantal equive and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the regulation and connect of 24 for Alance on to the regulation entitle If you desire specific advice for your acon of the same note the regulation entitled, the regulation entitled, contact the Office of Complance at (210) 270 - 10 - (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 - 1 - 4 Small " Misbranding by reference to premarket notified in the Act from the Division of Small
other general information on your responsibilities under the Act from pumber (800) 638other general information on your responsionnies ander at its toll-fire number (800) 638-2041 or Manufacturers, International and Consumer Assistance and carrers and consection index.html.
Sincerely yours,
signature
Miriam C. Provost, Ph.D. ન્ડર Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
This application || பட்டிப
Endolink™M True Movement System™
The Endolink™ True Movement System™ is mobilization, grasping, for intended dissection and transection of tissue under direct and endoscopic visualization.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K043541
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use · V (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
§ 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.