(121 days)
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.
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).
Here's an analysis of the provided text regarding the FemTec™ Laser Microkeratome, structured to address your specific questions about acceptance criteria and the supporting study:
The provided document is an Amendment to 510(k) K033354 for the FemTec™ Laser Microkeratome, cleared in 2004. It's important to note that this document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study reports or comprehensive acceptance criteria tables for novel device performance. Therefore, some of the requested information may not be explicitly present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen in clinical study reports. It relies on demonstrating equivalence to predicate devices. The primary "performance" mentioned is that the device was "found to perform equivalently to the Hansatome Microkeratome with respect to the creation of a corneal flap in an ex vivo study."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document only mentions an "ex vivo study."
- Data Provenance: "Ex vivo study." The country of origin is not mentioned, but the submitter (20/10 Perfect Vision GmbH) is based in Heidelberg, Germany, suggesting the study might have taken place there or in a related European location. It is by nature a prospective study on ex vivo tissue.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For an ex vivo study comparing flap creation, the "ground truth" (e.g., quality of flap, thickness, smoothness) would typically be assessed by ophthalmic specialists or researchers, but no details on their number or qualifications are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a surgical instrument (microkeratome), not an AI diagnostic tool that assists human readers.
- Effect Size of AI: Not applicable, as this is a device for creating corneal flaps, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an AI algorithm. The device itself (FemTec™ Laser Microkeratome) performs the laser microkeratome procedure. Its "standalone" performance would refer to its ability to create a corneal flap, which was assessed in the ex vivo study. The study implies that the device, functioning independently, achieved equivalent results to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies the ground truth for the ex vivo study was based on objective assessment of corneal flap creation characteristics (e.g., consistency, smoothness, depth) in comparison to the Hansatome Microkeratome. This would likely involve measurements and visual inspection, potentially by experts, but the specific methodologies are not detailed. It's not pathology, or outcomes data in the sense of patient follow-up, as it was an ex vivo study.
8. The sample size for the training set
This information is not applicable as the FemTec™ Laser Microkeratome is a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the FemTec™ Laser Microkeratome is a physical device, not a machine learning algorithm.
Summary of Device Performance (Based on available text):
| Performance Aspect | Reported Device Performance (FemTec™ Laser Microkeratome) | Acceptance Criteria (Implicit/Explicit) | Study Type |
|---|---|---|---|
| Corneal Flap Creation | Found to perform equivalently to the Hansatome Microkeratome with respect to the creation of a corneal flap. | Equivalence to predicate device (Hansatome Microkeratome) in corneal flap creation. | Ex vivo study |
Study Details:
- Test Set Sample Size: Not specified.
- Data Provenance: Ex vivo study.
- Number of Experts for Ground Truth: Not specified.
- Qualifications of Experts: Not specified.
- Adjudication Method: Not specified.
- MRMC Comparative Effectiveness Study: No (not applicable for this device type).
- Standalone Performance (in AI context): Not applicable. The device's "standalone" performance in creating flaps was the subject of the ex vivo study.
- Type of Ground Truth: Objective assessment of corneal flap characteristics, likely via measurements and visual inspection in comparison to a predicate device.
- Training Set Sample Size: Not applicable (not an AI algorithm).
- Ground Truth for Training Set: Not applicable (not an AI algorithm).
In conclusion, the document provides a 510(k) summary demonstrating substantial equivalence primarily through technological characteristics and a single ex vivo study comparing flap creation to a predicate device. It lacks the detailed quantitative acceptance criteria and specific study methodology (e.g., sample sizes, expert details, adjudication) typically found in comprehensive clinical study reports for devices undergoing more rigorous novel technology review.
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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 21/169123 HeidelbergGermany |
| C. | Company Phone:Company Fax: | 49-6221-7502-11049-6221-7502-121 |
| D. | Contact Person: | Dr. Frieder LoeselCEO, 20/10 Perfect Vision GmbH |
| E. | Date Summary Prepared: | January 30, 2004 |
| DEVICE IDENTIFICATION | ||
| A. | Classification Name: | 1. Keratome2. Laser Surgical Instrument for use in Generaland 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:
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| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Pulsion FS LaserKeratome | Intralase Corp. | K013941 | February 27, 2002 |
| HansatomeMicrokeratome | Bausch & LombSurgical | 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
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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.
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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.
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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
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Indications for Use
| 510(k) Number (if known): | K033354 |
|---|---|
| Device Name: | FemTec™ Laser Microkeratome |
| Indications For Use: | The FemTec™ Laser Microkeratome is indicated for usein the creation of a corneal flap in patients undergoingLASIK surgery or other treatment requiring initial lamellarresection 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
§ 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.