(91 days)
Not Found
Not Found
No
The summary describes a standard CO2 surgical laser and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any description of training or test data sets which would be necessary for an AI/ML device.
Yes
The device is a surgical laser intended for cutting, coagulation, and ablation of soft tissue, which are procedures for treating medical conditions.
No
The device is described as a surgical laser used for procedures like coagulation, vaporization, ablation, and cutting of soft tissue, which are all therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "Pulsed CO2 Surgical laser," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures (coagulation, vaporization, ablation, cutting of soft tissue) on the human body. IVDs are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a person's health.
- Device Description: The device is a surgical laser, which is a therapeutic device used directly on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory results.
Therefore, the Tru-Pulse™ Pulsed CO2 Surgical laser is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"clinical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open and endoscopic general surgery."
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
"Tru-Pulse™ Pulsed CO2 Surgical laser is an Rf excited gas-slab pulsed CO2 laser which produces 1-10 watts average power"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 NE
Albuquerque, 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, laser
79-GEX
21 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 average
power |
| Intended use of the Tru-Pulse™ CO2 Surgical Laser | This intended use is the same or similar to that for the
UltraPulse® 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: | None
None |
| Conclusion: | The intended us is the same or similar to that for the
UltraPulse 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 |
1
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.
2
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
3
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__________________________________________________________________________________________________________________________________________________________