(71 days)
Not Found
Not Found
No
The device description details a simple fiberoptic illuminator and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is used for illumination during ophthalmic surgery, which is a supportive function rather than directly providing a therapeutic effect.
No
The device is described as an illuminator "For illumination during ophthalmic surgery", indicating it provides light, not diagnostic information.
No
The device description explicitly lists hardware components such as a stainless steel needle, delrin handpiece, PMMA fiberoptic fiber, plastic cladding, and an aluminum connector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For illumination during ophthalmic surgery." This describes a device used during a surgical procedure to provide light, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a fiberoptic illuminator used for surgical illumination. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
Therefore, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For illumination during ophthalmic surgery
Product codes
HQE, MPA
Device Description
The American Medical Devices, Inc., 19 and 20 ga. Endolight™ Fiberoptic Endo- Illuminators are for illumination during ophthalmic surgery. The device consists of a stainless steel needle with a delrin handpiece, PMMA fiberoptic fiber with plastic cladding and an aluminum connector. This device connects to any conventional light source via an aluminum accessory adapter, which is packaged separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ophthalmic
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)
Not Found
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
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 black on a white square, followed by a series of vertical lines in black on a black square. To the right of the squares, the words "AMERICAN MEDICAL DEVICES, Inc." are printed in black, stacked vertically.
MAY 20 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 Fax: (404) 815-5235
Official Correspondent: Frank J. Tighe
Trade Name: The American Medical Devices, Inc., 19 and 20 Ga. Endolight™ Fiberoptic Endo-Illuminator.
Common Name: Fiberoptic Endo-Illuminator
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: HQE
Page 1 Summary
1
Device Description: The American Medical Devices, Inc., 19 and 20 ga. Endolight™ Fiberoptic Endo- Illuminators are for illumination during ophthalmic surgery. The device consists of a stainless steel needle with a delrin handpiece, PMMA fiberoptic fiber with plastic cladding and an aluminum connector. This device connects to any conventional light source via an aluminum accessory adapter, which is packaged separately.
Statement of indications for use. - For illumination during ophthalmic surgery.
| Substantial Equivalence Comparison
Substantial Equivalence Comparison | American Medical
Devices, Inc. | Storz | Grieshaber & Co |
|-----------------------------------------------------------------------------------|-----------------------------------|-------|-----------------|
| Packaging
Tyvek to Poly | X | X | X |
| For illumination
During ophthalmic surgery | X | X | X |
| Materials: Stainless Steel Needle,
PMMA Fiberoptic Fiber, Delrin
Handpiece, | X | X | X |
| Aluminum Connector | X | | X |
| Sterilization ETO | X | X | X |
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
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is relatively small compared to the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1997
Mr. Frank J. Tighe American Medical Devices, Inc. 1100 Northside Drive Atlanta, GA 30318
Re: K970875 Trade Name: Endolight™ Fiberoptic Endo-Illuminator 19 and 20 ga. Regulatory Class: II Product Code: MPA Dated: February 27, 1997 Received: March 10, 1997
Dear Mr. Tighe:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Flectronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Frank J. Tighe
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) 594-4613. 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 at (301) 443-6597.
Sincerely yours,
Aleryl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for American Medical Devices, Inc. The logo consists of a large letter "A" in black on a white square, followed by a series of vertical lines in white on a black background. To the right of these elements, the words "AMERICAN MEDICAL DEVICES, Inc." are stacked vertically in a bold, sans-serif font.
1100 Northside Drive Atlanta, Georgia 30318
(510(k) Number (if known): K970875
Device Name: The American Medical Devices, Inc 19 and 20 ga. Endolight™ Fiberoptic Endo-Illuminator
Indications For Use:
For illumination during ophthalmic surgery
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Ophthalmic Devices |
| 510(k) Number | K970875 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format i-2-96) |