(68 days)
The Cutera Titan Tabletop Product with an infrared handpiece is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Cutera Titan Tabletop Product may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The Cutera Titan Tabletop Product consists of a modified console designed to drive the infrared handpiece, which is an existing, FDA cleared attachment for the existing, FDA cleared laser. The handpiece is an infrared handpiece with a variable emission of 0.8 to 2.0 microns (850 - 3000 nm). The delivered wavelength is filtered to 1100nm - 1800nm via coated glass filters to eliminate the extraneous wavelengths.
The Cutera Titan Tabletop Product is comprised of five main components:
- a system console (including software and control electronics);
- a control and display panel;
- a detachable handpiece with integrated skin cooling;
- a foot-operated exposure switch (footswitch); and
- a remote interlock connector (disables emission when treatment room door is opened).
The proximal end of the umbilical cable is semi-permanently attached to the laser system console and the distal end is permanently attached to the body of the delivery hand piece. This hand piece is removable by either the user or an authorized field service engineer for replacement at the proximal end.
The provided information describes a 510(k) submission for the Cutera Titan Tabletop Product. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with specific acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not applicable to this submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
Not applicable. This 510(k) submission demonstrates substantial equivalence to existing cleared devices rather than providing specific performance metrics against pre-defined acceptance criteria from a new study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new clinical trials or studies with test sets were conducted for this 510(k) submission. The evidence relies on the substantial equivalence to previously cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new clinical trials or studies requiring expert-established ground truth were conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new clinical trials or studies with test sets were 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
Not applicable. This device is an infrared treatment product, not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical infrared treatment product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new clinical trials or studies requiring ground truth were conducted for this 510(k) submission.
8. The sample size for the training set
Not applicable. This submission is not for an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This submission is not for an AI/machine learning model that requires a training set.
Summary of the K042165 Submission for the Cutera Titan Tabletop Product:
The Cutera Titan Tabletop Product gained 510(k) clearance by demonstrating substantial equivalence to existing, legally marketed predicate devices. The core argument for substantial equivalence is based on:
- Identical Indications for Use: The new device shares the exact same indications for use as the previously cleared infrared handpiece (K033768). These indications include temporary relief of minor muscle and joint pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation, and relaxation of muscles, as well as helping muscle spasms, minor sprains, strains, and minor muscular back pain.
- Technological Substantial Equivalence: The Cutera Titan Tabletop Product consists of a modified console designed to drive an existing, FDA-cleared infrared handpiece (with a variable emission of 0.8 to 2.0 microns, filtered to 1100nm - 1800nm). The console (K023954) and the infrared handpiece (K033768) are both previously cleared components.
- Comparable Risks and Benefits: Due to the identical indications for use and technological similarity to predicate devices, the manufacturer argued that the risks and benefits are comparable and that no new questions of safety or effectiveness are raised.
Therefore, the "study" proving the device meets acceptance criteria, in this context, is the comparison and justification of substantial equivalence to the predicate devices (Cutera Optional Infrared Handpiece K033768 and the base console K023954), as outlined in the 510(k) summary. This process relies on regulatory review of design, materials, and functional specifications against established predicates, rather than new clinical data against specific performance metrics.
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K042165 p1/2
Premarket Notification 510(k) Submission: Cutera Titan Tabletop Product
Attachment 12 510(k) Summary for the Cutera Titan Tabletop Product
I. General Information
| Submitter: | Cutera, Inc.3240 Bayshore BoulevardBrisbane, CA 94005 |
|---|---|
| ------------ | --------------------------------------------------------------- |
Kathy Maynor Contact Person:
Summary Preparation Date: September 17, 2004
Names II.
| Device Names: | Cutera Titan Tabletop Product |
|---|---|
| Primary Classification Name: | Laser Powered Surgical Instrument (and Accessories) |
Predicate Devices UII.
- . Cutera Optional Infrared Handpiece
IV. Product Description
The Cutera Titan Tabletop Product consists of a modified console designed to drive the infrared handpiece, which is an existing, FDA cleared attachment for the existing, FDA cleared laser. The handpiece is an infrared handpiece with a variable emission of 0.8 to 2.0 microns (850 - 3000 nm). The delivered wavelength is filtered to 1100nm - 1800nm via coated glass filters to eliminate the extraneous wavelengths.
The Cutera Titan Tabletop Product is comprised of five main components:
- a system console (including software and control electronics); t
- t a control and display panel;
- a detachable handpiece with integrated skin cooling; .
- a foot-operated exposure switch (footswitch); and .
- a remote interlock connector (disables emission when treatment room door is opened). .
The proximal end of the umbilical cable is semi-permanently attached to the laser system console and the distal end is permanently attached to the body of the delivery hand piece. This hand piece is removable by either the user or an authorized field service engineer for replacement at the proximal end.
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Premarket Notification 510(k) Submission: Cutera Titan Tabletop Product
V. Indications for Use
The Cutera Titan Tabletop Product with an infrared handpiece is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Cutera Titan Tabletop Product may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
VI. Rationale for Substantial Equivalence
The Cutera Titan Tabletop Product shares the same general indications for use, and therefore is substantially equivalent to the currently cleared infrared handpiece (K033768) and the currently cleared base console (K023954).
VII. Safety and Effectiveness Information
The indication for use is exactly the same as the previously cleared infrared handpiece (K033768).
Technologically, the Cutera Titan Tabletop Product is substantially equivalent to the listed predicate device. Therefore the risks and benefits for the Cutera Titan Tabletop Product are comparable to the predicate devices.
We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of this device.
VIII. Conclusion
The Cutera Titan Tabletop Product was found to be substantially equivalent to the currently cleared infrared handpiece (K033768) and base console (K023954). The Cutera Titan Tabletop Product shares similar indications for use, design features, and similar functional features as, and thus are substantially equivalent to, the currently marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
OCT 1 8 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cutera, Inc. c/o Mr. Morten S. Christensen FDA Office Coordinator Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050
Re: K042165
Trade/Device Name: Cutera Titan Tabletop Product Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: September 28, 2004 Received: September 29, 2004
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave rowled your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abor naturing 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Morten S. Christensen
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse FDA finding of substantial equivalence of your device to a legally premailed predicated. The 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), please if you atent office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification 510(k) Submission: Cutera Titan Tabletop Product
Attachment 2 Indications For Use Statement as Requested by FDA
K042165 510(k) Number (if Known):
Device Name: Cutera Titan Tabletop Product
Indications For Use:
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joint pain associated with arthritis, in et the Titles Treulation Product may a joint pain associated with artimis, the Cutera Titan Titan Titan Troduct may also help muscle
the relaxation of muscles. In addition, the Cutera Titan Tanksely min the relaxation of muscles. In addinor muscular back pain.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K042165
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.