(76 days)
No
The summary describes a mechanical surgical device with no mention of AI/ML capabilities, image processing, or data-driven performance metrics.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is used for surgical procedures like ligation and transection of tissue, which are actions performed during surgery, not treatments for a condition.
No
Explanation: The device description clearly states its functions are "ligation and transection of isolated vessels and other structures," which are surgical procedures, not diagnostic ones.
No
The device description clearly outlines physical components like a tube, handle assembly, cutting blade, grasping jaws, and a clip delivery system, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is used in open and endoscopic surgery for ligation and transection of tissue, blood vessels, ducts, and other structures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a surgical instrument with a cutting blade, grasping jaws, and a clip delivery system. These are all components used for physical manipulation of tissue during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose disease, or monitor treatment.
IVD devices are used to perform tests on samples taken from the body, not to perform surgical procedures directly on the body.
N/A
Intended Use / Indications for Use
The Origin Ligator Device has applications in open and endoscopic surgery. It is primarily indicated for patients undergoing endoscopic surgery that require ligation or ligation and transection of tissue including blood vessels, ducts and other structures in the extremies, extraperitoneal space, abdominal cavity and the chest wall. It is indicated for patients undergoing surgical procedures in the extremities including but not limited to saphaenous vein harvesting for peripheral or coronary artery bypass grafting.
Product codes
GCJ
Device Description
The Origin Ligator Device is a single-use endoscopic device with dual functions of ligation and transection of isolated vessels and other structures. It consists of a tube, handle assembly, and located at the distal end of the tube is the cutting blade, grasping jaws, and a clip delivery system. The cutting blade is activated independently from the grasping jaws and the clip delivery system. The Origin Ligator Device will allow both clipping and cutting operations to be performed multiple times without removing the device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremies, extraperitoneal space, abdominal cavity and the chest wall
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Origin Ligator Device
ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION
Class I
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
OCT - 1 1997 This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.
1972685
21 CFR $807.92 a(1)
ORIGIN® Medsystems, Inc. Submitter: 135 Constitution Avenue Menlo Park, CA 94025 (415) 617-5142 contact person: Anthony Durso date prepared: July 10, 1997
21 CFR $807.92 a(2)
Trade name:
Origin Ligator Device
Ligator Common name: Manual Surgical Instrument Classification name:
21 CFR §807.92 a(3)
Identification of predicate(s): Substantial equivalence for the Origin Ligator Device is based on its similarities to predicate device: the ORIGIN AcuClip® Endoscopic Multiple Clip Applier, (K920599; 7/15/92),. It shares in material, and technological characteristics as the predicate device. The Origin Ligator Device is also similar in intended use.
21 CFR $807.92 a(4)
Device Description-parts and function/concept: The Origin Ligator Device is a single-use endoscopic device with dual functions of ligation and transection of isolated vessels and other structures. It consists of a tube, handle assembly, and located at the distal end of the tube is the cutting blade, grasping jaws, and a clip delivery system. The cutting blade is activated independently from the grasping jaws and the clip delivery system. The Origin Ligator Device will allow both clipping and cutting operations to be performed multiple times without removing the device
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and head. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT - 1 1997
Ms. Cynthia G. Royster Manager, Regulatory Affairs ORIGIN Medsystems, Inc. 135 Constitution Avenue Menlo Park, California 94025
Re: K972685
Trade Name: The Origin Ligator Device Regulatory Class: II Product Code: GCJ Dated: July 10, 1997 Received: July 17, 1997
Dear Ms. Royster:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Cynthia G. Royster
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
1972685
The Origin Ligator Device __
has applications in open and endoscopic surgery. It Indications For Use: is primarily indicated for patients undergoing endoscopic surgery that require ligation or ligation and transection of tissue including blood vessels, ducts and other structures in the extremies, extraperitoneal space, abdominal cavity and the chest wall. It is indicated for patients undergoing surgical procedures in the extremities including but not limited to saphaenous vein harvesting for peripheral or coronary artery bypass grafting.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE).
| Prescription Use | X |
|---|---|
| OR | |
| Over-The-Counter Use |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K972685 |
|---|---|
| (Optional Format 1-2-96) |