(85 days)
Not Found
No
The description mentions a "microprocessor controlled device" that generates "precisely defined repeatable patterns in an automated sequence." This indicates programmed automation, not AI/ML which typically involves learning from data to perform tasks. There are no mentions of AI, ML, or related concepts, nor any descriptions of training or test data sets which are fundamental to AI/ML development.
No.
The device itself is an accessory that generates patterns for a laser and does not directly provide therapy. The therapeutic action comes from the laser it is used with, which is indicated for soft tissue ablation and skin resurfacing.
No
The device is described as an "Accessory for use with the CB Erbium / 2.94TM Er:YAG Laser for general dermatology (soft tissue ablation) and skin resurfacing in the treatment of wrinkles." It "generates precisely defined repeatable patterns in an automated sequence to increase treatment speed and facilitate uniform ablation of tissue." This description indicates its function is entirely therapeutic (ablating tissue), not diagnostic. There is no mention of it acquiring, analyzing, or interpreting any physiological data to determine the presence, nature, or extent of a disease or condition.
No
The device description explicitly states it is a "microprocessor controlled device" that "generates precisely defined repeatable patterns," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general dermatology (soft tissue ablation) and skin resurfacing in the treatment of wrinkles." This describes a therapeutic or surgical procedure performed directly on the patient's body.
- Device Description: The description focuses on how the device facilitates the laser treatment process by generating patterns for tissue ablation. This is a physical interaction with the tissue, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of a specimen.
Therefore, this device falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For general dermatology (soft tissue ablation) and skin resurfacing in the treatment of wrinkles.
Product codes
GEX
Device Description
The Scanning Device Accessory is a microprocessor controlled device that generates precisely defined repeatable patterns in an automated sequence to increase treatment speed and facilitate uniform ablation of tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, skin
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
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics
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
| 510(k) Summary | AUG 1 4 1997 | ||
|---|---|---|---|
| Submitter: | Continuum Biomedical | ||
| A Medical Division of Continuum Electro-Optics, Inc. | |||
| 6533 Sierra Lane | |||
| Dublin, CA 94568 | |||
| Contact: | Robert S. Anderson, Ph.D. | ||
| President | |||
| Date Summary Prepared: | May 20, 1997 | ||
| Device Trade Name: | Scanning Device Accessory for the CB Erbium / 2.94TM Er:YAG Laser | ||
| Common Name: | Medical laser system | ||
| Classification Name: | Instrument, surgical, powered, laser | ||
| 79-GEX | |||
| 21 CFR 878.48 | |||
| Equivalent Device: | SoftScanTM Scanning Device, Sahar Technologies, Inc. (K964684) | ||
| Device Description: | The Scanning Device Accessory is a microprocessor controlled device | ||
| that generates precisely defined repeatable patterns in an automated | |||
| sequence to increase treatment speed and facilitate uniform ablation of | |||
| tissue. | |||
| Intended Use: | For general dermatology (soft tissue ablation) and skin resurfacing in | ||
| the treatment of wrinkles | |||
| Comparison: | The Scanning Device Accessory for the CB Erbium / 2.94 TM Er:YAG | ||
| Laser is manufactured for Continuum Biomedical by Sahar | |||
| Technologies, Inc. (K964684, SE 02/14/97). | |||
| Nonclinical Performance Data: | none | ||
| Clinical Performance Data: | none | ||
| Conclusion: | The Scanning Device Accessory for the CB Erbium / 2.94 TM Er:YAG | ||
| Laser enhances the clinical application procedure while maintaining the | |||
| performance characteristics. | |||
| Additional Information: | None requested at this time. |
1
Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, with three wavy lines representing the body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laurie A. Ridener Regulatory Affairs Officer Continuum Biomedical, Inc. 6533 Sierra Lane Dublin, California 94568
AUG 1 4 1997
Re: K971879
Trade Name: Scanning Device Accessory for use with the CB Erbium/2.94TM Er: YAG Laser Regulatory Class: II Product Code: GEX Dated: May 20, 1997 Received: May 21, 1997
Dear Ms. Ridener:
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 (OS) 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
2
Page 2 - Ms. Laurie A. Ridener
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.
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,
toscellef
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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Page 1 of 1
971879
| 510(k) Number (if known): | pending |
|---|---|
| Device Name: | --CB Erbium / 2.94™ Er:YAG Laser |
| Indications for Use: | Scanning Device Accessory for use with the CB Erbium / 2.94™ |
| Er:YAG Laser for general dermatology (soft tissue ablation) and | |
| skin resurfacing in the treatment of wrinkles. |
(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 | K971879 |
| Prescription Use | |
| (Per 21 CFR 801.109) | OR Over-the-Counter Use |
(Optional Format 1-2-96)