(88 days)
- To be used for cooling therapy when applied to the affected body surface during a migraine headache and for the reduction of pain from muscle spasms associated with migraine headaches.
IVC™ device
This is a 510(k) clearance letter for the IVC™ device, a water circulating hot or cold pack. The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new study to prove its safety and effectiveness.
Therefore, the provided document does not contain the acceptance criteria or a study proving the device meets those criteria because it's a substantial equivalence determination.
Here's why and what information would typically be needed if it were a de novo submission or required clinical data:
Why the requested information isn't in this document:
- Substantial Equivalence (510(k)): The FDA's 510(k) pathway determines if a new device is "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use and technological characteristics as the predicate, or if it has different technological characteristics, those differences do not raise different questions of safety and effectiveness.
- No New Clinical Data Required: For most 510(k) clearances, clinical studies demonstrating specific device performance against acceptance criteria are not required. Manufacturers typically provide information comparing their device to a predicate, often using bench testing, non-clinical data, or existing clinical literature on the predicate.
If this were a document for a device requiring clinical performance data, the following would be required:
- Acceptance Criteria Table: This would define specific thresholds (e.g., sensitivity, specificity, accuracy, precision, error rates, pain reduction scores, temperature control ranges) that the new device must meet to be considered safe and effective for its indicated use.
- Study Design and Results: Details of a clinical trial or performance study would be presented.
Let's address the specific points you asked for, even though they are not applicable to the provided document:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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 not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) clearance letter for an IVC™ device based on substantial equivalence, not a document detailing a performance study with acceptance criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 7 - 2004
Mark H. Friedman, DDS Westchester Head & Neck Pain Center 2 Overhill Road, Suite 260 Scarsdale, New York 10583
Re: K040317
Trade Name: IVC™ device Classification Regulation Name and Number: Water circulating hot or cold pack
21 CFR § 890.5720
Regulatory Class: Class II Exempt Product Code: ILO Dated: January 26, 2004 Received: February 9, 2004
Dear Dr. Friedman:
This letter corrects our exempt letter of May 7, 2004 regarding the IVC™ device.
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 (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 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 - Mark H. Friedman, DDS
This letter will allow you to continue 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 Office of Compliance at (301) 594-4659. 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 Manufacturers, International 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,
J. Mark A. Wilkerson
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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XII. Indication for Use: [Separate page]
510(k) Number: NA
Device Name: IVCTM (In Vitro Chilling) device.
Indications for Use:
- To be used for cooling therapy when applied to the affected body surface during a migraine headache and for the reduction of pain from muscle spasms associated with migraine headaches.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
Mark N. Milham
Sion Sign Jivision of General, Restorative, and Neurological Devices
.
or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Rep.p. 9
9
10
510(k) Number K040317
§ 890.5720 Water circulating hot or cold pack.
(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.