(86 days)
None
No
The summary describes a reprocessed laser probe, a physical accessory for a laser delivery system. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The focus is on the physical components and reprocessing procedures.
Yes
The device is a reprocessed laser probe that delivers laser energy to a treatment site in ophthalmic procedures, indicating its use in therapy.
No
Explanation: The device is described as a reprocessed laser probe used to deliver laser energy for treatment in ophthalmic procedures to a treatment site, not to diagnose a condition.
No
The device description explicitly states that the device consists of physical components such as a handpiece, fiber optic cable, and connector, and undergoes bench testing and process validation for cleaning and sterilization, 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: The intended use clearly states that these devices are "reprocessed laser probes... used in ophthalmic procedures where laser energy is the mode of treatment." This describes a device used in vivo (within the body) for therapeutic purposes (delivering laser energy for treatment).
- IVD Definition: In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
- Device Description: The description details a device that delivers energy to a treatment site through an opening at the probe tip, which is consistent with an in vivo application.
Therefore, this device is a therapeutic medical device used in ophthalmic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Reprocessed laser probes are part of a laser delivery system and are used in ophthalmic procedures where laser energy is the mode of treatment. These devices are reprocessed laser probes from various original equipment manufacturers (OEMs). Reprocessed laser probes are part of a laser delivery system and are used in ophthalmic procedures where laser energy is the mode of treatment.
Product codes
HQF, GEX
Device Description
Laser probes are an accessory used as part of a laser delivery system. They consist of a probe handpiece, strain relief, fiber optic cable, and connector. A laser light pipe may or may not be part of the probe. The probes must be connected to a laser console in order to deliver energy. The laser probe delivers the energy to the treatment site through an opening at the probe tip. Note, this submission is only in regard to the laser probe itself. It does not pertain to any other part of a laser delivery system such as the console.
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
Representative samples of reprocessed laser probes underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
SECTION 2. SUMMARY AND CERTIFICATION
| 510(k) Summary
| A. | NOV 0 8 2001 |
|---|---|
| Submitter: | SterilMed, Inc. |
| Contact Person: | Patrick Fleischhacker |
| 11400 73rd Avenue North | |
| Minneapolis, MN 55369 | |
| Ph: 888-856-4870 | |
| Fax: 763-488-3350 | |
| Date Prepared: | August 10, 2001 |
| Trade Name: | SterilMed Reprocessed Laser Probes |
| Classification Name: | Laser, Ophthalmic |
| Classification Number: | Class II, 21 CFR 886.4390 |
| Product Code: | HQF |
| Predicate Device(s): | SterilMed's reprocessed laser probes are substantially |
| equivalent to HGM Inc.'s Fleischman-Swartz Endo-Ocular | |
| Probe (K840590), and to the counterpart devices from the | |
| original manufacturers. | |
| Device Description: | Laser probes are an accessory used as part of a laser |
| delivery system. They consist of a probe handpiece, strain | |
| relief, fiber optic cable, and connector. A laser light pipe | |
| may or may not be part of the probe. The probes must be | |
| connected to a laser console in order to deliver energy. The | |
| laser probe delivers the energy to the treatment site through | |
| an opening at the probe tip. Note, this submission is only in | |
| regard to the laser probe itself. It does not pertain to any | |
| other part of a laser delivery system such as the console. | |
| Intended Use: | Reprocessed laser probes are part of a laser delivery system |
| and are used in ophthalmic procedures where laser energy | |
| is the mode of treatment. | |
| Functional and | |
| Safety Testing: | Representative samples of reprocessed laser probes |
| underwent bench testing to demonstrate appropriate |
.
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012682 2/2
functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
Conclusion:
SterilMed's reprocessed laser probes are substantially equivalent to HGM Inc.'s Fleischman-Swartz Endo-Ocular Probe (K840590), and to the counterpart devices from the original manufacturers. This conclusion is based upon the fact that these devices are essentially identical to the predicate device in terms of functional design, indications for use, and principles of operation.
2
Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 82001
Mr. Patrick Fleischhacker Vice President Regulatory and Quality Control SterilMed, Inc. 11400 73rd Avenue, North Minneapolis, Minnesota 55369
Re: K012682
Trade Name: Reprocessed Laser Probe Regulation Number: 886.4390 Regulation Name: Laser, ophthalmic Regulatory Class: Class II Product Code: GEX; HQF Dated: August 10, 2001 Received: August 14, 2001
Dear Mr. Fleischhacker:
We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Patrick Fleischhacker
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
Image /page/3/Picture/5 description: The image contains a black and white drawing of a signature. The signature appears to be cursive and somewhat stylized. The first letter is a large loop, and the rest of the signature is a series of connected strokes.
Celia M. Witten, Ph.D., M.D. S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KOi2682
Indications for Use Page
Device Name: Reprocessed Laser probes
Indications for Use:
These devices are reprocessed laser probes from various original equipment manufacturers (OEMs). Reprocessed laser probes are part of a laser delivery system and are used in ophthalmic procedures where laser energy is the mode of treatment.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Walker
(Division Sign- Off) Division of Ge eral, Restorative and Neurological Devices
510(k) Number
K0126sf2