(90 days)
The Pulsion™ FS is an ophthalmic surgical laser 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 Pulsion FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the PULSION FS Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
The provided text is a 510(k) summary for the Pulsion FS Laser, which is an ophthalmic surgical laser. The document claims substantial equivalence to a predicate device (Pulsion FS Laser with 510(k) K993153). While it states that the device has undergone testing and complies with safety standards, and performs equivalently in "extensive ex vivo and in vivo studies," it does not provide acceptance criteria or a detailed study report that proves the device meets specific performance criteria.
Therefore, most of the requested information cannot be extracted directly from the provided text.
Here's an attempt to answer based on the available information, with notes where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "found to perform equivalently to the predicate laser keratome, with respect to the creation of corneal resections in extensive ex vivo and in vivo studies." |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document only mentions "extensive ex vivo and in vivo studies."
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not specified.
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
- This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a surgical laser, not an algorithm. Therefore, a standalone algorithm performance study is not applicable. The device's performance relates to its physical action of creating corneal resections.
7. The type of ground truth used
- The document mentions "creation of corneal resections." The ground truth would likely involve measurement of the characteristics of the corneal resections created by the laser (e.g., flap thickness, diameter, smoothness, side-cut angle, tissue integrity) in both ex vivo and in vivo models. However, the specific type of measurement or gold standard definition is not detailed.
8. The sample size for the training set
- This documentation pertains to a surgical device, not a machine learning model that has a "training set." Therefore, the concept of a training set sample size is not applicable.
9. How the ground truth for the training set was established
- As a surgical device, there is no "training set" in the context of machine learning. The device's performance is established through direct physical testing and comparison to a predicate device.
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FEB 2 7 2002
SECTION 11
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
- Submitter's name, address, telephone number, contact person, and date summary 1. prepared;
- Applicant: a.
IntraLase Corp. 3 Morgan Irvine, CA 92618
- b. Contact Person:
J. Randy Alexander President and CEO
J. Randy Oliphley
November 26, 2001
Date Summary Prepared: C.
Name of device, including trade name and classification name: 2.
- Trade/Proprietary Name: Pulsion FS Laser a.
- b. Classification Name: Laser Keratome
- Identification of the predicate device or legally marketed device or devices to which 3. substantial equivalence is being claimed:
| Company: | IntraLase Corp. |
|---|---|
| Device: | Pulsion FS Laser |
| 510(k): | K993153 |
| Date Cleared: | December 17, 1999 |
-
- A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
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The Pulsion FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the PULSION FS Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
ડ. Statement of intended use:
The Pulsion™ FS is an ophthalmic surgical laser 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.
Statement of how the technological characteristics of the device compare to those of 6. the predicate or legally marketed device.
The technological characteristics of the Pulsion FS Laser have already been cleared under K993153 for lamellar corneal resections. The design, materials, and characteristics of the laser keratome are the same irrespective of the indication for use.
Brief summary of nonclinical tests and results: 7.
The Pulsion FS Laser has undergone testing and is in compliance with applicable safety standards. In addition, the Pulsion FS was found to perform equivalently to the predicate laser keratome, with respect to the creation of corneal resections in extensive ex vivo and in vivo studies. Thus, the Pulsion FS Laser and the predicate device have similar safety, effectiveness or performance profiles.
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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 image of an eagle with three lines forming its wing and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
FEB 2 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IntraLase Corporation c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 2 Delphinus Irvine, California 92612
Re: K013941 Trade/Device Name: Pulsion FS Laser Keratome Regulation Number: 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: November 26, 2001 Received: November 29, 2001
Dear Dr. Gordon:
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 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 - Judy F. Gordon, D.V.M.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse FDA finding of substantial equivalence of your device to a legally premaince hotification. The Pro intention 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 11 you desire specific and 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF IC For at 659. Additionally, for questions on the promotion and advertising of Compinatee at (301) 29 - 10th 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 Oiner general mistmances, 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,
L. Mark A. Miller
Celia 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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Page 1 of 1
510(k) Number (if known): KO13941
Pulsion FS Laser Device Name:
Indications for Use:
The Pulsion™ FS is an ophthalmic surgical laser indicated for use in the creation of a The Fusion - TO is an opinating LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription Use OR
Division Sign Off
Over-The-Counter Use (Optional Format 1-2-96)
ign-Off vision of General, Restorative and Neurological Devices
510(k) Number K013491
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§ 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.