(121 days)
Not Found
No
The description focuses on the mechanical and laser-based operation of the device for creating a corneal flap, with no mention of AI or ML for decision-making, image analysis, or other functions.
Yes
The device is used to create a corneal flap for LASIK surgery, which is a therapeutic procedure to correct vision problems.
No
The device is described as creating a corneal flap for surgery, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "Laser Microkeratome" that produces laser pulses and utilizes a disposable PMMA contact lens (Patient Interface), 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 is the "creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea." This is a surgical procedure performed directly on a living patient's tissue (the cornea).
- Device Description: The device description details a laser system used to create a dissection plane within the cornea using laser pulses and gas bubbles. This is a physical intervention on the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
This device is clearly used in vivo (within the living body) for a surgical procedure, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
The FemTec Laser Microkeratome is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Product codes
HNO, GEX
Device Description
The FemTec™ Laser Microkeratome is intended for use in the creation of a corneal flap by producing short bursts of laser pulses, with each laser pulse having a duration on the order of 500 to 1000 femtoseconds ("fs", 10-15 seconds). Microscopic gas bubbles, which form as a result of the laser induced optical breakdown (LIOB), arc created adjacent to each other at a pre-determined depth in the cornea. It is this continuous layer of gas bubbles that create the lamellar corneal dissection plane just like a mechanical microkeratome blade. The FemTec Laser Microkeratome creates a flap under very low vacuum (250 mbar), and delivers the laser energy directly to the stromal layer of the cornea through a disposable PMMA contact lens, referred to as the Patient Interface (PI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea
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)
The FemTec™ Laser Microkeratome has been designed and will be tested to applicable safety standards. In addition, the FemTec™ Laser Microkeratome was found to perform equivalently to the Hansatome Microkeratome with respect to the creation of a corneal flap in an ex vivo study.
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
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
Amendment to 510(k) K033354
FEB 1 8 2004
510(k) SUMMARY 20/10 Perfect Vision FemTec™ Laser Microkeratome
1. SUBMITTER INFORMATION
| A. | Company Name: | 20/10 Perfect Vision GmbH |
|---|---|---|
| B. | Company Address: | Am Taubenfeld 21/1 |
| 69123 Heidelberg | ||
| Germany | ||
| C. | Company Phone: | |
| Company Fax: | 49-6221-7502-110 | |
| 49-6221-7502-121 | ||
| D. | Contact Person: | Dr. Frieder Loesel |
| CEO, 20/10 Perfect Vision GmbH | ||
| E. | Date Summary Prepared: | January 30, 2004 |
| DEVICE IDENTIFICATION | ||
| A. | Classification Name: | 1. Keratome |
- Laser Surgical Instrument for use in General
and Plastic Surgery and in Dermatology |
| B. | Trade/Proprietary Name: | FemTec™ Laser Microkeratome |
| C. | Device Classification: | Class II (per 21 CFR 878.4810) |
| D. | Product Code: | HNO & GEX |
3. SUBSTANTIAL EQUIVALENCE
The FemTec™ Laser Microkeratome is of comparable type and is substantially equivalent to the following predicate devices:
1
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Pulsion FS Laser | |||
| Keratome | Intralase Corp. | K013941 | February 27, 2002 |
| Hansatome | |||
| Microkeratome | Bausch & Lomb | ||
| Surgical | K010260 | April 27, 2001 |
The materials, basic scientific concepts, and physical properties of the FemTec Laser Microkeratome are similar to those of the Intralase Pulsion FS Laser Keratome (and the indications for use are identical), and the indications for use for the FemTec Laser Microkeratome are identical to those of the Hansatome Microkeratome.
4. DEVICE DESCRIPTION
The FemTec Laser Microkeratome is intended for use in the creation of a corneal flap by producing short bursts of laser pulses, with each laser pulse having a duration on the order of 500 to 1000 femtoseconds ("fs", 10-15 seconds). Microscopic gas bubbles, which form as a result of the laser induced optical breakdown (LIOB), arc created adjacent to each other at a pre-determined depth in the cornea. It is this continuous layer of gas bubbles that create the lamellar corneal dissection plane just like a mechanical microkeratome blade. The FemTec Laser Microkeratome creates a flap under very low vacuum (250 mbar), and delivers the laser energy directly to the stromal layer of the cornea through a disposable PMMA contact lens, referred to as the Patient Interface (PI).
5. INDICATIONS FOR USE
The FemTecTM Laser Microkeratome is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
2
6. TECHNOLOGICAL CHARACTERISTICS
The 20/10 Perfect Vision FemTec™ Laser Microkeratome has technological characteristics very similar to those of the Intralase Pulsion FS Laser Keratome. The design, materials, and characteristics of the FemTec™ Laser Microkeratome are similar to those of the Pulsion FS Laser Keratome. The differences between the FemTec™ Laser Microkeratome and the Pulsion FS Laser Keratome are insignificant and do not affect the safety or effectiveness of the device.
PERFORMANCE DATA SUMMARY 7.
The FemTec™ Laser Microkeratome has been designed and will be tested to applicable safety standards. In addition, the FemTec™ Laser Microkeratome was found to perform equivalently to the Hansatome Microkeratome with respect to the creation of a corneal flap in an ex vivo study.
8. CONCLUSIONS
20/10 Perfect Vision GmbH has demonstrated through its evaluation of the FemTec™ Laser Microkeratome that the device is equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
FEB 1 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
20/10 Perfect Vision Optische Gerate GmbH c/o Ms. Carol Patterson Patterson Consulting Group 21911 Erie Lanc Lake Forest, California 92630
Re: K033354
Trade/Device Name: FemTecTM Laser Microkeratome Regulation Number: 21 CFR 878.4810, 886.4370 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology: Keratome Regulatory Class: II Product Code: GEX, HNO Dated: January 30, 2004 Received: February 3, 2004
Dear Ms. Patterson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 sct 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.
4
Page 2 - Ms. Carol Patterson
This letter will allow you to begin marketing your device as described in your Scction 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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
Sincercly yours,
L. Mark N. Milkerson
Cclia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
| 510(k) Number (if known): | K033354 |
|---|---|
| Device Name: | FemTec™ Laser Microkeratome |
| Indications For Use: | The FemTec™ Laser Microkeratome is indicated for use |
| in the creation of a corneal flap in patients undergoing | |
| LASIK surgery or other treatment requiring initial lamellar | |
| resection of the cornea. |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Modi Al-Mulkern
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K033354