(48 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of cryoanalgesia and nerve stimulation, with no mention of AI or ML technologies for control, analysis, or decision-making.
Yes
The device is described as "blocking pain by temporarily ablating the peripheral nerves," which is a therapeutic action. The text also mentions that it is used for "freezing nerves to block pain by temporary ablation" and "freezing of the nerve fibers creates a block which prevents the conduction of pain." These actions directly address a medical condition (pain) and aim to provide relief or treatment.
No.
The device is a cryoanalgesia system used for blocking pain by temporarily ablating peripheral nerves. While it includes a "peripheral nerve stimulator" to "facilitate the location of the peripheral nerve prior to freezing," its primary intended use is therapeutic (pain blocking through ablation), not diagnostic. The nerve stimulator is a tool to aid the therapeutic procedure, not to diagnose a condition.
No
The device description clearly outlines hardware components including consoles, cryoprobes, a footswitch, and gas tanks, which are integral to the device's function.
Based on the provided information, the Cryo-PaC™ systems are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "blocking pain by temporarily ablating the peripheral nerves." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description details a system that uses cryogen gas to freeze nerves for pain relief. This is an in-vivo treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the human body. The Cryo-PaC™ system is a therapeutic device used to treat a condition within the body.
N/A
Intended Use / Indications for Use
The Cryo-PaC systems are a series of cryoanalgesia devices intended for use in blocking pain by temporarily ablating the peripheral nerves.
Product codes (comma separated list FDA assigned to the subject device)
GXH
Device Description
The Cryo-PaCTM systems comprise a choice of three versions of a cryoanalgesia console: the base model Cryo-PaCTM, and the Cryo-PaCTM Plus and Cryo-PaCTM Ultra; all based on the same control module but providing a range of features for the control of the cryogen gas. The consoles are complemented by a range of cryoprobes that are used for freezing nerves to block pain by temporary ablation. The Cryo-PaC™ console is used to control the supply of gas to the cryoprobe and to provide an electrical nerve location device. A footswitch completes the system. A convenience procedure kit for probe placement is also provided as a single use disposable.
In the Cryo-PaC™ systems, compressed nitrous oxide or carbon dioxide is directed to the tip of the cryoprobe where it is allowed to expand through a fine annular space. The expansion of the gas to near atmospheric pressure causes cooling by the Joule Thompson effect. The design of the cryoprobes is such that the warmer incoming gas maintains the outer stem of the cryoprobe above freezing temperatures to prevent freczing up the stem of the cryoprobe and unwanted tissue damage. A peripheral nerve stimulator in the Cryo-PaC™ consoles facilitate the location of the peripheral nerve prior to freezing. Freezing of the nerve fibers creates a block which prevents the conduction of pain. The effect is usually non-permanent, and a repeat of the treatment may be necessary to deal with long term pain.
The Cryo-PaC™ consoles have been designed to provide a simple user interface, together with a series of error detection and warning systems to ensure proper operation. In the Cryo-PaCTM Plus and Ultra models the console includes a pedestal that provides a convenient small footprint mobile base for the system, and houses the gas tanks. A simple footswitch completes the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerves
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): 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.
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
§ 882.4250 Cryogenic surgical device.
(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).
0
K050272 510(k) Summary
February 1" 2005
1 Submitter
MAR 2 4 2005
Cryomedical Instruments Itd Cryomed House Grove Way Mansfield Woodhouse Mansfield Nottinghamshire NG19 8BW United Kingdom
| Contact Person: | Mr. Gareth Copping, Technical Director |
|---|---|
| Tel: | +44 1623 424200 |
| Fax: | +44 1623 424777 |
| E-mail: | gareth.copping@cryomed.co.uk |
2 Name of Device
| Proprietary Name: | Cryo-PaCTM systems, comprising:
a) Cryo-PaCTM console, Cryo-PaCTM Plus console
and Cryo-PaCTM Ultra console
b) Cryo-PaCTM 1.3 mm cryoprobe
d) Cryo-PaCTM 2.0 mm cryoprobe
e) Cryo-PaCTM 2.1 mm cryoprobe
f) Cryo-PaCTM 2.6 mm cryoprobe
g) Convenience procedure kit for probe placement |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cryoanalgesia System |
Cryogenic surgical devices have been placed in Class II as per Classification: 21 CFR Regulation Number 882.4250 and assigned the Product Code GXH
Predicate Devices 3
The components of the Cryo-PaC™ system are substantially equivalent to the following legally marketed devices:
| K031482 | Cryomedical Instruments CryoStarTM |
|---|---|
| K781302 | Spermbly Lloyd Neurostat® |
| K854334 | Wallach Painblocker WA5000 |
This statement is based on the similarity of the subject device to the predicate devices in intended use, materials, design and principles of operation.
1
Device Description 4
The Cryo-PaCTM systems comprise a choice of three versions of a cryoanalgesia console: the base model Cryo-PaCTM, and the Cryo-PaCTM Plus and Cryo-PaCTM Ultra; all based on the same control module but providing a range of features for the control of the cryogen gas. The consoles are complemented by a range of cryoprobes that are used for freezing nerves to block pain by temporary ablation. The Cryo-PaC™ console is used to control the supply of gas to the cryoprobe and to provide an electrical nerve location device. A footswitch completes the system. A convenience procedure kit for probe placement is also provided as a single use disposable.
In the Cryo-PaC™ systems, compressed nitrous oxide or carbon dioxide is directed to the tip of the cryoprobe where it is allowed to expand through a fine annular space. The expansion of the gas to near atmospheric pressure causes cooling by the Joule Thompson effect. The design of the cryoprobes is such that the warmer incoming gas maintains the outer stem of the cryoprobe above freezing temperatures to prevent freczing up the stem of the cryoprobe and unwanted tissue damage. A peripheral nerve stimulator in the Cryo-PaC™ consoles facilitate the location of the peripheral nerve prior to freezing. Freezing of the nerve fibers creates a block which prevents the conduction of pain. The effect is usually non-permanent, and a repeat of the treatment may be necessary to deal with long term pain.
The Cryo-PaC™ consoles have been designed to provide a simple user interface, together with a series of error detection and warning systems to ensure proper operation. In the Cryo-PaCTM Plus and Ultra models the console includes a pedestal that provides a convenient small footprint mobile base for the system, and houses the gas tanks. A simple footswitch completes the system.
5 Intended Use
The Cryo-PaCTM systems are a series of cryoanalgesia devices intended for use in blocking pain by temporarily ablating the peripheral nerves.
6 Summary of Substantial Equivalence
The Cryo-PaC™ systems are similar in design, intended use and performance characteristics to the predicate devices. There are now new issues of safety of effectiveness raised by the subject device.
2
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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2005
Mr. Gareth Copping Technical Director Cryomed Instruments Ltd Cryomed House Grove Way Mansfield Woodhouse Mansfield Notinghamshire NG19 8BW United Kingdom
Re: K050272
K020272 Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic surgical device Regulatory Class: II Product Code: GXH Dated: February 28, 2005 Received: March 1, 2005
Dear Mr. Copping:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premained is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regally the enactment date of the Medical Device Amendments. or to commence prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval approval application (PMA). allu Cosmetic Act (Tel) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration. Insting of general controls provisions of the rist lessent miss against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it If your device is classified (soo abore) this. Existing major regulations affecting your device can thay be subject to suen additional bonations, Title 21, Parts 800 to 898. In addition, FLA may be found in the Outs acements concerning your device in the Federal Register.
3
Page 2 - Mr. Gareth Copping
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease ve advisod that i Dr Shatian that your device complies with other requirements of the Act that I Dr has intact a and regulations administered by other Federal agencies. You must or any I cueral statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 007); adoling (21 CFR Part 820); and if applicable, the electronic form in the quality bywell be (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and will your he FDA finding of substantial equivalence of your device to a legally premative notifications "ceresults 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 in you active 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 golfiners, 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/industry/support/index.html.
Sincerely yours.
Euth
Miriam C. Provost, Ph Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if Known): | K050272 |
|---|---|
| Device Name: | Cryomedical Instruments Cryo-PaC™ Systems |
| Indications for Use: | The Cryo-PaC™ systems are a series of cryoanalgesia devices intended for use in blocking pain by temporarily ablating the peripheral nerves. |
X Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFGR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
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Signature
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