(71 days)
TECHNOSANAT KRYO TSK 2005 is intended for use in conjunction with a laser to provide surface cooling during cutaneous laser treatment and is a cooling device indicated for:
- The reduction of pain associated with laser treatment,
- Less discomfort.
- Cooling of the skin just before laser impulse treatment.
TECHNOSANAT KRYO TSK 2005 is a skin-cooling device designed for support of laser treatment. The device consists of a control device and the treatment applicator which are connected via hose lines. Cold is generated in the applicator by means of Peltierelement, and directed to the patient via a metallic finger transfer medium. A piece of cooled metal comes in contact with skin and performs skin cooling. The treatment temperature is recorded by means of one temperature sensor in the applicator and is then displayed on the device's temporatur controllar
The provided document is a 510(k) summary for the TECHNOSANAT KRYO TSK 2005 cooling device. It describes the device and its intended use, and states that it is substantially equivalent to predicate devices. However, it explicitly states that "performance data were not required" because "The specifications and intended uses of TECHNOSANT KRYO TSK 2005 are the same or very similar to those of claimed predicate devices."
Therefore, based solely on the provided text, there is no study described that proves the device meets specific acceptance criteria. The acceptance of the device for market clearance was based on its substantial equivalence to existing predicate devices, not on new performance data demonstrating it meets specific criteria through a study.
As such, many of the requested details about a study, acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted from this document as no such study is presented.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as new performance criteria for this device. The criteria for acceptance for market clearance was "substantial equivalence" to predicate devices.
- Reported Device Performance: "None. Performance data were not required."
2. Sample size used for the test set and the data provenance
- Not applicable as no performance study was conducted for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no performance study was conducted for this device.
4. Adjudication method for the test set
- Not applicable as no performance study was conducted for this device.
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
- No, this is a cooling device for laser treatment, not an AI diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical cooling device, not an algorithm.
7. The type of ground truth used
- Not applicable as no performance study was conducted for this device. Its approval was based on substantial equivalence to predicate devices, implying that the established safety and effectiveness of those predicates served as the basis for evaluation.
8. The sample size for the training set
- Not applicable as no performance study or machine learning model training was conducted for this physical device.
9. How the ground truth for the training set was established
- Not applicable as no performance study or machine learning model training was conducted for this physical device.
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Image /page/0/Picture/1 description: The image shows a black circle with a white rectangle in the middle. The word "TECHNOSANAT" is written in black capital letters inside the white rectangle. The background of the image is white.
TECHNOSANAT Innovative Medizintechnik Joerg Trempert, Gewerbepark Keplerstrasse 10 -12, 07549 Gera, Germany
510(k) SUMMARY
TECHNOSANAT KRYO TSK 2005
This 510(k) summary of safety and effectiveness for the TECHNOSANAT Innovative Medizintechnik TECHNOSANAT KRYO TSK 2005 is submitted in accordance with the requirements of 21 CFR Part 807 Subpart E § 807.92 and follows the DSMA Office of Health and Industry Programs Guidance: Premarket Notification 510(k) - Regulatory Requirements for Medical Devices (HHS Publication FDA 95-4158, August 1995) concerning the requirements for a 510(k) Summary and Statement.
| Applicant: | TECHNOSANATInnovative Medizintechnik |
|---|---|
| Address: | Gewerbepark Keplerstrasse 10 -1207549 Gera, Germany |
| Contact Person: | Joerg TrempertPresident |
| Phone:Fax:e-mail: | +49 365 7349 280+49 365 7349 289technosanat@tgz.gera.de |
| Preparation date: | July 10, 1999 |
| Device name: | Cooling device TECHNOSANAT KRYO TSK 2005 |
| Common Name: | TECHNOSANAT KRYO TSK 2005 |
| ClassificationName: | Cooling device as accasessory to a Laser surgical instrument for usein general and plastic surgery and in dermatology (21 CFR 878.4810)Product code: GEX - Laser instrument, surgical, poweredPanel: SU |
| Legally marketeddevices (SE): | The Technosanat Kryo TSK 2005 is substantially equivalent to the PalomarE2000 System, Laserscope Coolspot, Optimed Dermacool an the CandelaDynamic cooling device. The operating principle of these devices is topicalapplication of a low-temperature material to the surface of the skin in order toreduce its temperature. |
| See also Table of Comparison. | |
| Device Description: | TECHNOSANAT KRYO TSK 2005 is a skin-cooling device designed forsupport of laser treatment. The device consists of a control device and thetreatment applicator which are connected via hose lines. Cold is generated inthe applicator by means of Peltierelement, and directed to the patient via ametallic finger transfer medium. A piece of cooled metal comes in contact withskin and performs skin cooling. The treatment temperature is recorded bymeans of one temperature sensor in the applicator and is then displayed onthe device's temporatur controllar |
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| Intended Use: | TECHNOSANT KRYO TSK 2005 is intended for use in conjunction with alaser to provide surface cooling during cutaneous laser treatment and is acooling device indicated for:1. The reduction of pain associated with laser treatment,2. Less discomfort,3. Cooling of the skin just before the laser impulse treatment. |
|---|---|
| Comparison to: | The intended use of the TECHNOSANT KRYO TSK 2005 is substantiallyequivalent to predicate devices in that they are intended to reduce pain andminimize thermal injury to skin structures during laser therapy. |
| Performance data: | None. The specifications and intended uses of TECHNOSANT KRYO TSK2005 are the same or very similar to those of claimed predicate devices.Because of this, performance data were not required. |
| CONCLUSION: | The risks and benefits for the TECHNOSANT KRYO TSK 2005 arecomparable to the predicate devices when used for similar clinical applicationsand therefore is the TECHNOSANT KRYO TSK 2005 substantially equivalentto legally marketed devices. |
:
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 OCT
Technosant Innovative Medizintechnik, GMBH C/o Mr. William Kelley Aesculap-Meditec North America 2525 McGaw Avenue Irvine, California 92623
Re: K992536
Trade Name: TECHNOSANAT KRYO TSK 2005 Regulatory Class: II Product Code: GEX Dated: July 7, 1999 Received: July 29, 1999
Dear Mr. Kelley:
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 Ouality 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. William Kelley
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,
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 STATEMENT
510(k) Number (if known): K992536
Device Name: TECHNOSANAT KRYO TSK 2005
Indications For Use:
TECHNOSANAT KRYO TSK 2005 is intended for use in conjunction with a laser to provide surface cooling during cutaneous laser treatment and is a cooling device indicated for:
-
The reduction of pain associated with laser treatment,
-
Less discomfort.
-
Cooling of the skin just before laser impulse treatment.
Refer to the user manual for the laser to which the device is attached for cleared indications for use.
(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 K992536
510(k) Number
§ 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.