(248 days)
The Life Vessel™ is indicated to provide topical heating for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation.
The Life Vessel™ is a chamber in which the patient lays flat under the treatment light source and positions the part of the body to be treated under the light source. The system is also used for non-medical relaxation applications and for these purposes includes music and sound components for relaxation.
The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study that proves the device meets those criteria in a structured scientific manner, as one might expect from a medical device clinical trial report.
However, based on the information provided, we can infer the primary performance characteristic and the result of a study that addresses it.
Here's an interpretation based on the given text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Ability to increase skin temperature for therapeutic effects. | The system increases skin temperature to 40-45 degrees C. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It simply states "Performance data was submitted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The type of performance data described (skin temperature measurement) does not typically involve expert ground truth establishment in the same way an AI diagnostic device would.
4. Adjudication method for the test set
This information is not provided. Given the nature of the performance data (direct measurement of skin temperature), an adjudication method in the context of expert consensus or diagnostic agreement is likely not applicable or was not detailed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that an MRMC comparative effectiveness study was performed. The device is an infrared lamp for therapeutic heating, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "performance data" described is inherently a "standalone" performance of the device's ability to generate heat and increase skin temperature. There is no human-in-the-loop component described for this specific performance metric.
7. The type of ground truth used
The "ground truth" used is direct physiological measurement (skin temperature in degrees Celsius).
8. The sample size for the training set
The document does not provide information about a training set or its sample size. This type of device's performance demonstration typically relies on physical measurements rather than machine learning models that require training data.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or implied for this type of device's performance evaluation.
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510(k) Summary for The Life Vessel™
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
Contact Person:
Submitter:
Cottonwood Vessel Corp. 34 North Alamos Cottonwood, AZ 86326
NOV
1 6
2007
Miki Kolton Greenberg Traurig, LLP 800 Connectict Ave. NW, Suite 500 Washington, D.C. 20006
Summary Preparation Date:
March 9, 2007
2. Names
Device Name:
Classification Name:
Infrared Lamp
The Life Vessel™
Product Code: ILY
3. Predicate Devices
The Life Vessel™ is substantially equivalent to a combination of the Care Electronics, Inc. Dermillume Red HR1000 Lamp (K051681), the Quantum Devices, Inc. Quantum WARP 10 Light Delivery System (K032229), the Diomedics, Inc. Pain-X-2000 Models: 300, 600, 900, 1600, 2500 and 5700 (K982546), and the Light Force Therapy, Inc. Acubeam Super Nova, Dio (K022888).
4. Device Description
The Life Vessel™ is a chamber in which the patient lays flat under the treatment light source and positions the part of the body to be treated under the light source. The system is also used for non-medical relaxation applications and for these purposes includes music and sound components for relaxation.
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5. Indications for Use
The Life Vessel™ is indicated to provide topical heating for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation.
6. Performance Data
Performance data was submitted which demonstrated that the system increases skin temperature to 40-45 degrees C.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
NOV 1 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cottonwood Vessel Corporation % Ms. Miki Kolton Greenberg Traurig, LLP 800 Connecticut Avenue, NW Washington, DC 20006
Re: K070690 Trade/Device Name: Life Vessel Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: October 10, 2007 Received: October 10, 2007
Dear Ms. Kolton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 - Ms. Kolton
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark Melkerson Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: The Life Vessel™
Indications For Use:
The Life Vessel™ is indicated to provide topical heating for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
Page
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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, and Neurological Devices
| 510(k) Number | 1670692 |
|---|---|
| --------------- | --------- |
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§ 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.