(90 days)
The Ceralas G Frequency Doubled Nd:YAG Laser System and Accessories is intended as a surgical instrument for use in the photocoagulation of: ocular tissue, and vascular and pigmented skin lesions.
The Ceralas G3 is a complete, self-contained, compact surgical laser system that utilizes a diode pumped neodymium-doped yttrium aluminum garnet (Nd:YAG) laser whose output is frequency doubled to produce radiation in the green visible spectrum at 532 nm. Frequency doubling is achieved by the use of an intercavity Potassium Titanyl Phosphate ("KTP") crystal. KTP is a crystalline material that has nonlinear optical properties which allows the input of light of one color and output of a different light color. Specifically, it allows infrared light in and emits green light. The laser employs a modular design which includes: 1) laser crystal; 2) cooling module; 3) built in power meter with automatic calibration; 4) continuous or pulsed operating modes; and 5) front controls with a display panel. The laser system delivers up to 3 Watts of optical power. The exposure mode for the laser is selectable from 0.10 Watts to 3 Watts at 532 nm. The delivery systems for the Ceralas G Frequency Doubled Nd: Y AG Laser Systems consist of an optical fiber in a coaxially mounted protective sheath which is fitted with an SMA connector at the proximal end. The fiber is a bare, polished quartz fiber provided in a 200 micron to 1400 micron diameter range. The delivery systems are hand-held, designed to fit the Ceralas G3, and deliver the laser energy via the SMA connector which couples it to the laser. The Ceralas the delivery systems are supplied sterile.
This 510(k) premarket notification describes the Ceralas G Frequency Doubled Nd:YAG Laser System (Ceralas G3) and its substantial equivalence to previously cleared devices. The submission primarily focuses on adding a new indication for use: "photocoagulation of vascular and pigmented skin lesions."
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" or present a study comparing the device's numerical performance against such criteria. Instead, it argues for substantial equivalence based on technological characteristics and intended use matching predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (vs. Predicate) |
|---|---|
| Intended Use | Identical intended use (photocoagulation) |
| Principle of Operation | Similar (solid-state, diode-pumped frequency-doubled Nd:YAG) |
| Technological Characteristics | Similar (532nm wavelength, continuous/pulsed modes, 0.1-3 Watts power, air-cooled, fiber optic delivery) |
| Safety and Effectiveness | No new questions of safety or effectiveness raised by differences in dimensions/weight. Anticipated "same" laser tissue interaction and surgical performance. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study with a defined sample size is mentioned for the new indication. The submission relies on establishing substantial equivalence to existing cleared devices rather than providing new clinical data for this specific product. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission does not describe a study involving the establishment of ground truth by experts for a test set. The claim of equivalence is based on technical specifications and prior regulatory approvals of predicate devices.
4. Adjudication Method
Not applicable. There is no adjudicated test set described in the submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission does not discuss human readers or AI assistance.
6. Standalone Performance Study
No standalone performance study for the algorithm (device) is described in the provided text. The submission focuses on device characteristics and substantial equivalence, not on a new performance evaluation for the device itself.
7. Type of Ground Truth Used
Not applicable. Since no new clinical study or test set is presented for the Ceralas G3 for this new indication, there is no 'ground truth' defined for such a study. The "ground truth" implicitly relies on the FDA's prior clearance of predicate devices and the established safety and effectiveness of those technologies for similar indications.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML product, and therefore no training set or associated sample size is mentioned.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device and does not involve a training set.
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JUN 25 1998
510(k) SUMMARY
Ceralas G Frequecy Doubled Nd:YAG Laser Systems (including the Ceralas G3 Laser and Accessories)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Submitted by Regulatory Counsel for:
CeramOptec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 413-525-0600 Phone: Facsimile: 413-525-0611
Carol Morello, V.M.D. Contact Person:
Date Prepared: March 26, 1998
Name of Device and Name/Address of Sponsor
Ceralas G Frequency Doubled Nd: YAG Laser System and Accessories("Ceralas G3")
CeramOptec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Common or Usual Name
Frequency Doubled Nd: YAG Laser
Classification Name
Laser surgical instrument for use in general and plastic surgery and in dermatology.
Predicate Devices
CeramOptec's Ceralas G Frequency Doubled Nd:YAG Laser System and Accessories (K954834, K923953, K943445, and K951775), the Iris Medical DioLite 532 (K964074), and the Continuum Biomedical CB Diode/532 Laser (K954905).
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Intended Use
The Ceralas G Frequency Doubled Nd:YAG Laser System, the Ceralas G3 laser and accessories, is intended as a surgical instrument for use in the photocoagulation of vascular and pigmented skin lesions.
Technological Characteristics and Substantial Equivalence
The Ceralas G3 is a complete, self-contained, compact surgical laser system that utilizes a diode pumped neodymium-doped yttrium aluminum garnet (Nd:YAG) laser whose output is frequency doubled to produce radiation in the green visible spectrum at 532 nm. Frequency doubling is achieved by the use of an intercavity Potassium Titanyl Phosphate ("KTP") crystal. KTP is a crystalline material that has nonlinear optical properties which allows the input of light of one color and output of a different light color. Specifically, it allows infrared light in and emits green light. The laser employs a modular design which includes: 1) laser crystal; 2) cooling module; 3) built in power meter with automatic calibration; 4) continuous or pulsed operating modes; and 5) front controls with a display panel. The laser system delivers up to 3 Watts of optical power. The exposure mode for the laser is selectable from 0.10 Watts to 3 Watts at 532 nm. The Ceralas G3 is identical to the Ceralas G Frequency Doubled Nd: YAG Laser Systems that has already received clearance from FDA (K954834). The Ceralas G has already been cleared for the intended use as a surgical instrument for photocoagulation and is indicated for use in ocular tissue. This submission adds an additional indication for the Ceralas G as a surgical instrument for photocoagulation of vasculare and pigmented skin lesions.
The delivery systems for the Ceralas G Frequency Doubled Nd: Y AG Laser Systems consist of an optical fiber in a coaxially mounted protective sheath which is fitted with an SMA connector at the proximal end. The fiber is a bare, polished quartz fiber provided in a 200 micron to 1400 micron diameter range. The delivery systems are hand-held, designed to fit the Ceralas G3, and deliver the laser energy via the SMA connector which couples it to the laser. The Ceralas the delivery systems are supplied sterile. These systems are identical to those MegaBeam Fiber Optic Delivery Systems, which range in fiber sizes of 200 to 1200 micron diameters, and have already been cleared by the FDA. CeramOptec, the manufacturer of the MegaBeam Fiber Optic Delivery Systems, has previously obtained clearance for the use of these delivery systems as accessories to laser systems for any indication for which compatible Nd:YAG, 1.44 YAG, Ho:YAG, KTP, Argon and Diode laser systems are cleared (K923953, K943445, and K951775). This submission includes additional fiber sizes up to a 1400 micron diameter.
The Ceralas G3 has the same intended use, similar principles of operation and similar technological characteristics as previously cleared predicate laser systems. The
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Ceralas G3 and its predicate devices, the CeramOptec Ceralas G Frequency Doubled Nd: YAG Laser Systems (K954834), the Iris Medical Diolite 532 (K964074), and the Continuum Biomedical, Inc. CB Diode/532 Laser System (K954905), have the identical intended use.
The Ceralas G3, like its predicate device, is a solid state laser that emits a beam in the near-infrared region of the electromagnetic spectrum. Furthermore, the Ceralas G3, the Iris Medical Diolite 532 (K964074), and the Continuum Biomedical, Inc. CB Diode/532 (K954905), all employ diode pumped frequency doubled neodymium doped yttrium aluminum garnet laser crystals to generate the treatment beam. The wavelength of all of these lasers is 532nm. Each of the lasers offers continuous and pulsed exposure modes. Thus, the laser tissue interaction and the surgical performance of the Ceralas G3, the Iris Medical Diolite 532, and the Continuum Biomedical, Inc. CB Diode/532, would be expected to be the same.
The Ceralas G3 and all of the predicate devices (K964074, K954905, and K954834) exhibit comparable power outputs of 0.1 to 3 Watts and all are air cooled. All of these devices utilize essentially the same types of fiber optic delivery accessories to transmit the laser energy to the target tissue. The Ceralas G3 delivery systems and the predicate device delivery systems likewise operate in the contact and non-contact modes. The Ceralas G3 fiber delivery systems are available with fiber core diameters of 200 to 1400 microns similar to the Diolite 532 predicate device delivery systems (K964074).
Any differences between the Ceralas G3 and the predicate devices, such as the systems' dimensions and weight, do not raise new questions of 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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1998
CeramOptec, Inc. c/o Mr. Jonathan S. Kahan, Esquire Hogan & Hartson, L.L. P. Columbia Square 555 Thirteenth Street, NW Washington, District of Columbia 20004-1109
Re: K981126
Ceralas G Frequency Doubled ND: YAG Laser Systems and Trade Name: Accessories ("Cerales G3")
Regulatory Class: II Product Code: GEX Dated: March 27, 1998 Received: March 27, 1998
Dear Mr. Kahan:
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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.
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Page 2 - Mr. Kahan
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) 594-4595. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Jocuesta
Celia M. Witten, Ph.D., M.D. Director Division of General and · Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Page __ 1_ of ________________________________________________________________________________________________________________________________________________________________
| 510(k) Number (if known): | K 98112 b |
|---|---|
| --------------------------- | ----------- |
Ceralas G Frequency Doubled Nd: YAG Laser System and Accessories Device Name:
Indications For Use:
The Ceralas G Frequency Doubled Nd:YAG Laser System and Accessories is intended as a surgical instrument for use in the photocoagulation of:
: : : ocular tissue, 1)
and
vascular and pigmented skin lesions. 2)
(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 General Restorative Devices | |
| 510(k) Number | K981126 |
| Prescription Use __________ | |
|---|---|
| OR | |
| Over-The-Counter Use __________ |
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
| Prescription Use __________ | |
|---|---|
| (Per 21 CFR 801.109) |
§ 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.