(54 days)
The Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.
Needle-Point Suture Passer Instrument Set
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device (Carter-Thomason Needle-Point Suture Passer Instrument Set), confirming its substantial equivalence to a predicate device.
While it mentions the device's intended use ("to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery"), it does not include any specifics regarding:
- Acceptance criteria: No performance metrics or thresholds are listed.
- Device performance data: No study results, sensitivity, specificity, accuracy, or other performance indicators are provided.
- Sample sizes: No information about test sets, training sets, or data provenance.
- Ground truth establishment: No details on experts, adjudication methods, or the type of ground truth used.
- Comparative effectiveness studies (MRMC) or standalone algorithm performance: These concepts are not applicable to the type of device described (a surgical instrument, not an AI/software device).
The document is a regulatory approval, not a technical report detailing the device's validation study. Therefore, I cannot populate the requested table or answer the specific questions based on the given input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark Sterrett · Regulatory Affairs Specialist Louisville Laboratories 2400 Crittenden Drive Louisville, Kentucky 40217-1865
MAR - 9 1998
Re: K980123 Trade Name: Carter-Thomason Needle-Point Suture Passer Instrument Set Regulatory Class: II Product Code: GCJ Dated: January 12, 1998 Received: January 14, 1998
Dear Mr. Sterrett:
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 Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with =============================================================================================================== the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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 . requlations.
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Page 2 - Mr. Sterrett
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.
Cel ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _K980123
Device Name: Needle-Point Suture Passer Instrument Set
Indication For Use:
ﻣﺴﻠﺴﻠﺔ
The Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.
(PLEASE DO NOT WRITE BELOW THIS LNE - CONTINUE ON ANOTHER PAGE IF NECESSAY)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| -- | -------------------------------------------------------- | -- |
| Prescription Use | OR | Over-The Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Division of General Restorative Devices
| 510(k) Number | K980123 | (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.