(57 days)
For illumination during surgery. Regular Monofilament - Inserts into any standard Fiberoptic Pic Set. Fine Monofilament - Inserts into any standard Fiberoptic Forceps.
The American Medical Devices Endolight™ Regular and Fine Monofilaments are for illumination during surgery. The Regular Monofilament inserts into any standard pic set. The Fine Monofilament inserts into any standard fiberoptic forceps. These fibers allow the surgeon to use bi-manual technique during surgical procedures. The devices are identical except for the fact that the Regular Monofilament is a 19 ga. fiber and the Fine Monofilament is a 20 ga. fiber.
This is a 510(k) premarket notification for a medical device (fiberoptic monofilaments for surgical illumination), not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement typically associated with evaluating AI/ML device performance.
The document focuses on demonstrating substantial equivalence to predicate devices, sterilization methods, and material descriptions. It does not involve any algorithm performance, human-in-the-loop studies, or standalone algorithm evaluations.
As such, I cannot extract the requested information regarding AI/ML device performance and evaluation from this document.
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K 970878
Image /page/0/Picture/1 description: The image shows the logo for American Medical Devices, Inc. The logo consists of a large letter "A" in a white square, followed by a black rectangle with white vertical lines. To the right of these shapes is the text "AMERICAN MEDICAL DEVICES, Inc." in a bold, sans-serif font. The text is stacked vertically, with each word on a separate line.
MAY -6 1997
1100 Northside Drive Atlanta, Georgia 30318
February 27, 1997
Premarket Notification [510(k)] Summary
Submitter: American Medical Devices, Inc 1100 Northside Drive Atlanta, GA 30318 Phone: (404) 815-5233 (404) 815-5235 Fax:
Official Correspondent: Frank J. Tighe
Trade Name: The American Medical Devices, Inc., 19 and 20 Ga. Endolight™ Regular and Fine Monofilaments.
Common Name: Fiberoptic Bare End Fiber.
Registration Number: We have registered but have not received our application back as of this date.
Class: Class II
Class Name: We were unable to find the device listed in the classification regulations, 21 CFR Parts 862-892 [807.87 (c)].
Panel: Ophthalmic
Product Code: MPA
Device Description: The American Medical Devices Endolight™ Regular and Fine Monofilaments are for illumination during surgery. The Regular Monofilament inserts into any standard pic set. The Fine Monofilament inserts into any standard fiberoptic forceps. These fibers allow the surgeon to use bi-manual technique during surgical procedures. The devices are identical except for the fact that the Regular Monofilament is a 19 ga. fiber and the Fine Monofilament is a 20 ga. fiber. Please see Device Replica Diagram in Appendix C.
| Page 1 Summary | |||
|---|---|---|---|
| Toll-Free | Direct | Facsimile | Internet |
| 800-793-1473 | 404-815-5233 | 404-815-5235 | ftighe@americanmedicaldevices.com |
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Statement of indications for use. - For illumination during surgery. Regular Monofilament - Inserts into any standard Fiberoptic Pic Set. Fine Monofilament - Inserts into any standard Fiberoptic Forceps.
| Substantial Equivalence Comparison | American MedicalDevices, Inc. | Gamp & Assoc. | Grieshaber |
|---|---|---|---|
| PMMA Fiber | X | X | X |
| PMMA Cladding | X | X | X |
| Aluminum Connector | X | X | X |
| For Illumination During Surgery | X | X | X |
| ETO Sterilized | X | X | X |
The American Medical Devices, Inc Regular and Fine Monofilaments are produced and sterilize same locations as the Grieshaber products.
Sterility
The Device will be ETO Sterilized.
The method used to validate the sterilization cycle is AAMI Overkill Method
Packaging Material: Tyvek Pouch with a Ploymylar Sheath.
The SAL is 10 to the -6.
The maximum levels of residues of ethylene oxide: 25 parts per million; ethylene chlorohydrin: 25 parts per million and ethylene glycol: 250 parts per million.
This device is non-pyrogenic and the LAL Method is used to make that determination.
Pyrogens: We control the manufacturing environment to lessen the likelihood of pyrogen causing bacteria. In addition the LAL Method is used to determine that each lot is non-pyrogenic.
Page 2 Summary
§ 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.