(91 days)
Coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
Tru-Pulse™ Pulsed CO2 Surgical laser is an Rf excited gas-slab pulsed CO2 laser which produces 1-10 watts average power
Here's an analysis of the provided text regarding the acceptance criteria and study for the Tru-Pulse CO2 Surgical Laser System:
Based on the provided K970804 510(k) Summary, no specific acceptance criteria or study demonstrating device performance against those criteria are presented.
The submission is a 510(k) Pre-market Notification seeking substantial equivalence to a predicate device. In this type of submission, the primary goal is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not necessarily to independently prove performance against specific acceptance criteria through a dedicated study.
Here's a breakdown of the requested information based on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This indicates that no specific performance metrics or acceptance thresholds were established or measured for this submission. The basis for clearance is substantial equivalence to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not applicable, as no dedicated performance study using a test set was conducted for this 510(k) submission.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as no dedicated performance study with ground truth establishment was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no dedicated performance study with adjudication was conducted.
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 MRMC study was done. The device in question is a surgical laser, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- A standalone performance study was not done. The device is a physical surgical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no dedicated performance study with ground truth was established for this submission.
8. The sample size for the training set
- Not applicable, as this is a physical medical device (surgical laser), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as this is a physical medical device (surgical laser).
Summary of the 510(k) Submission:
The K970804 submission for the Tru-Pulse™ CO2 Surgical Laser relies entirely on substantial equivalence to an existing predicate device, the UltraPulse® Pulsed CO2 Laser manufactured by Coherent.
- Predicate Device: UltraPulse® Pulsed CO2 Laser manufactured by Coherent.
- Basis for Equivalence: The intended use of the Tru-Pulse™ is stated as "the same or similar" to the predicate device for various clinical applications (dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open and endoscopic general surgery).
- Performance Data: Crucially, the document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This signifies that the substantial equivalence argument was not supported by new performance studies specific to the Tru-Pulse™ device demonstrating its performance against predefined criteria. Instead, it likely relied on the established safety and effectiveness of the predicate device and the similarity of the new device's design and intended use.
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Attachment I 510(K) Summary Tru-Pulse CO2 Surgical Laser System
JUN - 3 1997
This 510(K) Summary of safety and effectiveness for the Tissue Technologies, Inc. Tru-Pulse™ CO2 Surgical Laser system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant:Address: | Tissue Technologies, Inc.4432 Anaheim NEAlbuquerque, NM 87113 |
|---|---|
| Contact Person: | Sandra Hansen, Regulatory Affairs |
| Telephone: | (505) 828-0508(505) 828-0525 |
| Preparation Date: | 3-1-97 |
| Device Trade Name: | Tru-Pulse™ CO2 Surgical Laser |
| Common Name: | CO2 Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX21 CFR 878-48 |
| Legally Marketed Predicate Device: | UltraPulse® Pulsed CO2 Laser manufactured by Coherent |
| Description of the Tru-Pulse™ CO2 Surgical Laser | Tru-Pulse™ Pulsed CO2 Surgical laser is an Rf excited gas-slab pulsed CO2 laser which produces 1-10 watts averagepower |
| Intended use of the Tru-Pulse™ CO2 Surgical Laser | This intended use is the same or similar to that for theUltraPulse® Pulsed CO2 Laser manufactured by Coherent,i.e. "clinical applications in dermatology, plastic surgery,podiatry, neurosurgery, gynecology, otorhinolaryngology,arthroscopy, open and endoscopic general surgery. |
| Nonclinical Performance Data:Clinical Performance Data: | NoneNone |
| Conclusion: | The intended us is the same or similar to that for theUltraPulse Pulsed CO2 laser marketed by Coherent, i.e.:Clinical applications in dermatology, plastic surgery,podiatry, neurosurgery, gynecology, otorhinolaryngology,arthroscopy, open and endoscopic general surgery. |
| Additional Information: | None requested at this time |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with its wings spread and its head turned to the right. The eagle is composed of several thick, curved lines, giving it a stylized appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Ms. Sandra Hansen Regulatory Affairs Tissue Technologies, Inc. 4432 Anaheim NE Albuquerque, New Mexico 87113
Re: K970804
Trade Name: Tru-Pulse™ CO2 Surgical Laser Regulatory Class: II Product Code: GEX Dated: March 1, 1997 Received: March 4, 1997
Dear Ms. Hansen:
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 vour 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 Good Manufacturing Practice for Medical Devices: General (GMP) rogulation (21 CFR Part 820) and that, through periodic GMP 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 - Sandra Hansen
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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INDICATION FOR USE STATEMENT
E970904 510(k) Number:
Device Name: Tru-Pulse™ CO2 Surgical Laser
Indications for Use:
Coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
(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 | K970804 |
Prescription Use_X (per 21 CFR 801.109) OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.