(88 days)
Schwartz Electro-Optics, Inc. CRL 2940 Erbium CrystaLase, Continuum Biomedical CB Erbium/2.94
No
The 510(k) summary describes a laser device for surgical procedures and skin treatments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The focus is on the laser's capabilities and intended uses.
Yes
The device is indicated for use in various surgical procedures involving cutting, vaporizing, ablating, and coagulating soft tissue, cartilage, and for skin resurfacing and treatment of wrinkles, which are all therapeutic interventions aimed at treating medical conditions or improving health.
No
The device is indicated for surgical procedures involving cutting, vaporizing, ablating, and coagulating soft tissue and cartilage, and also for skin resurfacing and the treatment of wrinkles, which are therapeutic rather than diagnostic actions.
No
The 510(k) summary describes a laser device (Schwartz Electro-Optics, Inc. CLR 2940) used for surgical procedures, which is a hardware device. The submission is requesting an expanded indication for use for this existing hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for surgical procedures (cutting, vaporizing, ablating, coagulating soft tissue and cartilage, skin resurfacing, wrinkle treatment). These are direct interventions on the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The description clearly indicates a surgical laser, which is a therapeutic device used on the patient, not a diagnostic device used with patient samples.
N/A
Intended Use / Indications for Use
As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles.
Specialties are:
- General Surgery
- Plastic Surgery,
- Podiatry
- Urology
- Gynecology
- Pulmonary Surgery
- Dermatology
- Gastroenterology
- Ophthalmology
- ENT
- Thoracic Surgery
- Oral and Maxillofacial Surgery
These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. is simply requesting the addition of skin resurfacing and the treatment of wrinkles.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small and large joints, soft tissue, cartilage, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Schwartz Electro-Optics, Inc. CRL 2940 Erbium CrystaLase, Continuum Biomedical CB Erbium/2.94
Reference Device(s)
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
JAN 1 2 1998
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS: VIII.
From a technology perspective, theory of operation the predicate device is the same as the Schwartz Electro-Optics, Inc. CRL 2940 Erbium CrystaLase. The laser mediums are the same, the systems are similar both mechanically and electronically. Schwartz Electro-Optics, Inc. believes that the technological characteristics of the CLR 2940 are similar to the predicate device, the Continuum Biomedical CB Erbium/2.94.
In regards to safety and effectiveness of the Schwartz Electro-Optics, Inc. CLR 2940 Erbium Laser, Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns.
- This information was prepared for the sole purpose of compliance with the Safe Advisory: Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
1
Image /page/1/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 design of three human profiles facing right, arranged in a stacked formation. The profiles are abstract and interconnected, creating a sense of unity. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1998
Mr. Timothy J. Shea Director of Solid State Laser Division Schwartz Electro-Optics, Incorporated 3404 N. Orange Blossom Trail Orlando, Florida 32804
K974039 Re:
Trade Name: Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase Regulatory Class: II Product Code: GEX Dated: October 16, 1997 Received: October 16, 1997
Dear Mr. Shea:
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 requirements , as set forth in the Quality System ... Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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
2
Page 2 - Mr. Shea
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.
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.
Sincerely, yours,
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
3
K974039
Food and Drug Administration
Office of Device Evaluation Document Mail Center (HFZ - 401) 9200 Corporate Boulevard Rockville, Maryland 20850
Oct 16 10 54 AM '97
FDA/CDRH/ODE/DMC
Reference: K071404
Indication for Use
As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles.
Specialties are:
-
- General Surgery
-
- Plastic Surgery,
-
- Podiatry
-
- Urology
-
- Gynecology
-
- Pulmonary Surgery
-
- Dermatology
-
- Gastroenterology
-
- Ophthalmology
-
- ENT
-
- Thoracic Surgery
-
- Oral and Maxillofacial Surgery
These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. is simply requesting the addition of skin resurfacing and the treatment of wrinkles.
| Prescription Use | _____________________________________________________________________________________________________________________________________________________________ |
|---|---|
| (Per 21 CFR 801.109) |