(78 days)
Not Found
No
The description focuses on mechanical articulation and manipulation, with no mention of AI/ML terms or functions.
No.
The device is described as an instrument for grasping, mobilization, dissection, and transaction of tissue, which are surgical functions rather than therapeutic ones aimed at treating a disease or condition. Its comparison to predicate devices like "Endopath Endoscopic Instruments" and "Pivotal Grasper / Dissector / Scissors" further supports its classification as a surgical tool, not a therapeutic device.
No
The device is described as an instrument for grasping, mobilization, dissection, and transaction of tissue, indicating it is an operative device rather than one used for diagnosis.
No
The device description explicitly states it consists of physical components like a handle, jaws, and a shaft, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "grasping, mobilization, dissection and transaction of tissue under direct and endoscopic visualization." This describes a surgical instrument used on the patient's body during a procedure.
- Device Description: The description details a surgical instrument with a handle, jaws, and shaft, designed for use through incisions or trocars. This is consistent with surgical tools, not devices used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to perform tests on these types of samples to diagnose conditions, monitor treatment, or screen for diseases.
Therefore, the Endolink™ True Movement System™ is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Endolink™ True Movement System™ is intended for grasping, mobilization, dissection and transaction of tissue under direct and endoscopic visualization.
Product codes
GCJ
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 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 (of scissors or blade) are opened or 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.
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
Not Found
Intended User / Care Setting
Not Found
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
Product testing was conducted to evaluate conformance to product specifications for grasping, manipulating, cutting and suturing of tissue. Testing comparing the Endolink Instruments to a commercially available predicate product was conducted. The results showed the Endolink Instruments were equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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 Road | |
| Suite A | |
| Cupertino, CA 95014 | |
| Tel: 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 Instruments
Ethicon Endo-Surgical, Inc. |
|---------|----------------------------------------------------------------|
| K972510 | Pivotal Grasper / Dissector / Scissors
Imagyn 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
1
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.
2
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.
3
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
4
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)