(146 days)
The Histofreezer V indications for use as follows: l, 1,1,2-tetrafluoroethane, pentafluoroethane, and l, 1,1-tri fluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
The Histofreezer V device utilizes extreme cold to facilitate the removal of benign topical lesions. The device utilizes a combination of 1.1.1.2-Tetrafluoroethane. Pentafluoroethane, and 1,1,1-Trifluoroethane delivered from the cannister of gas into a foam bud or cone which acts as a reservoir for the cryogen gas. To perform the treatment the bud or cone facilitates freezing the targeted lesion for up to 40 seconds .. The frozen lesion falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.
The provided text is a 510(k) Premarket Notification from the U.S. FDA for the Histofreezer V device. This document does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study that proves a device meets such criteria. Instead, it focuses on demonstrating substantial equivalence of the Histofreezer V, a cryosurgical unit, to a predicate device (CryoDose/McKesson) based on its technological characteristics and performance (specifically temperature attainment).
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance for an AI/ML device, as this information is not present in the provided text.
The text does include:
- A comparison of the Histofreezer V with its predicate device, CryoDose/McKesson (K130995), highlighting similarities in intended use, cryogen, cryogen gas boiling point, cone materials, mode of use, mechanism of action, safety, operation, and defined operators.
- A brief mention of "bench testing" that focused on "demonstrating the equivalency of temperatures over their treatment times while using cone or applicators from the CryoDose/McKesson device and Histofreezer V."
- A statement that the product was tested for biocompatibility according to FDA's guidance and ISO 10993 requirements.
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June 10, 2024
CryoConcepts LP Sam Niedbala Chief Executive Officer 1100 Conrov Place Easton, Pennsylvania 18040
Re: K240106
Trade/Device Name: Histofreezer V Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: May 10, 2024 Received: May 10, 2024
Dear Sam Niedbala:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long H. Chen -S Digitally signed by Long H. Chen-S
Digitally signed Date: 2024.06.10 11:18:27 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Histofreezer V (N/A)
Indications for Use (Describe)
The Histofreezer V indications for use as follows:
l, 1,1,2-tetrafluoroethane, pentafluoroethane, and l, 1,1-tri fluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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PREMARKET NOTIFICATION 510(K) SUMMARY
I. SUBMITTER
CryoConcepts LP, 1100 Conroy Place Easton, PA 18040 Phone: 855-355-2796 Contact: Dr. Sam Niedbala Prepared 29 December 2023
II. DEVICE
Name of Device: Histofreezer V
Usual Name – Cryosurgical unit and accessories Classification Name - General & Plastic Surgery Regulatory Class: GEH Product Code: GEH
III. PREDICATE DEVICES
K130995: CryoDose (Private Label McKesson Brand)
IV. DEVICE DESCRIPTION
The Histofreezer V device utilizes extreme cold to facilitate the removal of benign topical lesions. The device utilizes a combination of 1.1.1.2-Tetrafluoroethane. Pentafluoroethane, and 1,1,1-Trifluoroethane delivered from the cannister of gas into a foam bud or cone which acts as a reservoir for the cryogen gas. To perform the treatment the bud or cone facilitates freezing the targeted lesion for up to 40 seconds .. The frozen lesion falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.
V. INDICATIONS FOR USE:
The Histofreezer V indications for use are as follows:
1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-tri fluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
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| Characteristics | Histofreezer VSubject Device | CryoDoseMcKesson Private LabelK130995 |
|---|---|---|
| Intended Use | Tetrafluoroethane,Pentafluoroethane, andTrifluoroethane is to be used for thetreatment of:verruca (warts), including plantar and common warts, seborrheic keratoses, actinic keratoses, Facial and non-Facial achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma small keloids, granuloma annulare, porokeratosis plantaris, angiomas, lentigo maligna, keratoacanthoma basal cell carcinoma, bowen's disease, lentigo discrete, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, kaposi's sarcoma pyogenic granuloma | Tetrafluoroethane,Pentafluoroethane, andTrifluoroethane is to be used forthe treatment of:verruca (warts), including plantar and common warts, seborrheic keratoses, actinic keratoses, Facial and non-Facial achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, lentigo maligna, keratoacanthoma, basal cell carcinoma, bowen's disease, lentigo discrete, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, kaposi's sarcoma pyogenic granuloma |
| Cryogen | Mixture of Tetrafluoroethane,Pentafluoroethane, andTrifluoroethane | Mixture of Tetrafluoroethane,Pentafluoroethane, andTrifluoroethane |
| Cryogen Gas Boiling Point | -48(°C) | -48(°C) |
| Cone Materials | Plastic cones of various sizes Sizes Include: 3, 5, 7, 9,12, 16mm | Plastic cones of various sizes Sizes Include: 3, 5, 7, 9, 12, 16mm |
| Mode of Use | Dispense cryogen against the insidewall of the cone and let evaporate ordispense onto foam applicator whichis applied to the lesion | Dispense cryogen against theinside wall of the cone and letevaporate or dispense onto foamapplicator which is applied to thelesion |
| Mechanism of action | Cryogen is delivered to the skin bydispensing into the cone or foamapplicator | Cryogen is delivered to the skinby dispensing into the cone orfoam applicator |
| Characteristics | Histofreezer VSubject Device | CryoDoseMcKesson Private LabelK130995 |
| Safety | Non-Flammable | Non-Flammable |
| Operation | Gas dispense initiated by applyingpressure to the actuator and stoppedby taking pressure off actuator. | Gas dispense initiated by applyingpressure to the actuator andstopped by taking pressure offactuator. |
| Defined Operators | Licensed Medical Professionals (Rx) | Licensed Medical Professionals(Rx) |
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
A summary of the technological characteristics for the Histofreezer V versus the predicate devices: McKesson. Each uses the same combination of gases to treat the lesion using an applicator or cone. Each has the same indications for use.
VII. PERFORMANCE DATA
Cryosurgery works to destroy target lesions through applied extreme cold. When sufficient heat has been removed from the treated spot, the tissue is destroyed through cell lysis and vascular stasis.
The Histofreezer V device utilizes a mixture of 1,1,2-Tetrafluoroethane, Pentafluoroethane, and 1,1,1-Trifluoroethane delivered from the cannister of gas into a foam bud applicator or cone which acts as a reservoir for the cryogen gas. The predicate CryoDose/McKesson device use this same mixture known as R404A Gas.
Bench testing in this submission focused on demonstrating the equivalency of temperatures over their treatment times while using cone or applicators from the CryoDose/McKesson device and Histofreezer V.
Finally, as part of the data provided, the product was tested for biocompatibility including cytotoxicity, sensitivity, irritation according to FDA's biocompatibility guidance and meets the requirements of ISO 10993.
VIII. CONCLUSIONS
Various types and mixtures of refrigerants are well-established and used in cryosurgical products to achieve sufficiently low temperatures to effect tissue destruction through extreme cold temperatures. The comparison bench testing of the CryoDose/McKesson device compared to the Histofreezer V shows that the temperatures attained are sufficient for cryosurgery. The data, the labelling and bench data supplied supports the substantial equivalence between Histofreezer V and the predicate devices.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.