(189 days)
K-891152, K-891151, K-902269, K-920581, K-914434, K-935841, K-945067, K-915196
K-891152,K-891151,K-902269,K-920581,K-914434,K-935841,K-945067,K-915196
No
The device description and intended use focus on a mechanical cooling system and do not mention any AI/ML components or functions.
Yes
The device is intended to provide temporary relief of minor aches and pains, muscle spasms, or bruises by cooling a portion of the body, which are therapeutic effects.
No
Explanation: The device is described as cooling a portion of the body to provide temporary relief of aches, pains, muscle spasms, or bruises. This is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like metal/plastic tubes, a hollow metal tip, a small pump, and disposable plastic sheaths, indicating it 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 to cool a small portion of the body for temporary relief of minor aches, pains, muscle spasms, or bruises. This is a therapeutic application performed on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system for applying cold therapy externally to the body. It involves circulating ice water through a metal tip applied to the skin. This is a physical therapy device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the Cryotron, as described, falls under the category of a physical therapy or pain relief device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- These products have the same intended use, to cool a small portion of the body to provide temporary relief of minor aches and pains and muscle spasms or bruises. These are as those of the predicate devices. These products also have intended uses as similar products currently cleared for marketing by the 510(k) process, and several that are exempt (CFR 890.5700) that are exempt from 510(k) requirements.
Product codes
891LO*, 89IME
Device Description
Cryotron is fabricated by joining two hollow metal or plastic tubes together into a hollow metal tip which is shaped to fit over the maxillary nerve section or other area selected for cold therapy. Ice water driven by a small pump enters the smaller ube and exits the large tube, chilling the metal which is covered by a disposable plastic sheath. The product will be sold non-sterile; prepackaged, presterilized plastic sleeves will be provided with the Cryotron.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-891152, K-891151, K-902269, K-920581, K-914434, K-935841, K-945067, K-915196
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
XL SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND March 20, 1996 EFFECTIVENESS.
A. Submitter: Dr. Mark Friedman, 660 Gramatan Ave., Mi. Vernon, NY
- I. Classification Names and numbers: Hot or cold pack, water-circulating, 891LO* Cold pack, reusable, 89IME
II. Common/Usual Names: Cold Pack
ーー・・・・
III. Proprietary Names: Cryotron™ Cold Probe
JUN 1 0 1996
IV. Establishment Registration Number: In process
V. Classification: Circulating water cold packs have been classified in the Code of Federal Regulations, in class II, CFR 890,5720 by the Physical Medicine Panel, and placed in Tier II by the Office of Device Evaluation
VI. Performance Standard: None established under section 514.
VII. Description of the Device: Cryotron is fabricated by joining two hollow metal or plastic tubes together into a hollow metal tip which is shaped to fit over the maxillary nerve section or other area selected for cold therapy. Ice water driven by a small pump enters the smaller ube and exits the large tube, chilling the metal which is covered by a disposable plastic sheath. The product will be sold non-sterile; prepackaged, presterilized plastic sleeves will be provided with the Cryotron.
VIII. Labels of the product and competitive devices are provided.
IX. Substantial Equivalence Statement. The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:
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These products have the same intended use, to cool a small portion of the body to provide temporary relief of minor aches and pains and muscle spasms or bruises. These are as those of the predicate devices. These products also have intended uses as similar products currently cleared for marketing by the 510(k) process, and several that are exempt (CFR 890.5700) that are exempt from 510(k) requirements.
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The technological characteristics for this product are the same as those for the predicate devices and those currently on the market. The Cryotron probe is a common reusable type, made of chrome-plated brass and is sold non-sterile. The pump, cooler, and tubing are of plastic similar to that used in equivalent products. The plastic cover is disposable and is sold packaged separately.
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Descriptive information provided shows that the materials from which the Cryotron device are made is substantially equivalent to (nearly identical with) those of similar products, used for identical purposes, currently on the market. 0000000
1
3. Predicate devices
This device is substantially equivalent to preamendment devices classified as shown above. Specifically, the Cryotron device for which we are seeking marketing clearance is described in item 1. However, variations of this device, used in this office for the same purpose include an ice-extrusion pack which could be considered as an item 2 product, exempt from 510(k) requirements.
The device also is substantially equivalent to devices currently on the market such those sold by Kinetic Concepts, Inc. K-891152 and K-891151; Seabrook Medical Systems, K-902269; Breg, Inc., K-920581, K-914434; Toronto Medical Corp., K-935841; Electro-Biology, Inc., K-945067 and others. Labels and labeling for the Seabrook Medical Systems, Electri-Cool as well as for simpler systems such as EBIce by Electron Biology, Inc. and DeltaTherm by DeltaTherm, Inc. (to which the Cryotron is most similar) are shown for comparison in Attachment III. The device is also very similar to Hollister's System 3 (K-915196).
- Descriptive information provided shows that the materials from which the Cryotron device are made is substantially equivalent to (nearly identical with) those of similar products, used for identical purposes, currently on the market.
End of Summary