(88 days)
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No
The document describes a cryosurgical system that controls probes and monitors temperature. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, data analysis, or decision-making.
Yes
The device is intended to destroy tissue by applying extreme cold temperatures to treat conditions and diseases, including prostate cancer, benign prostatic hyperplasia, cancerous or malignant tissue, benign tumors, skin lesions, warts, and other conditions and diseases across various medical specialties. This directly aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a cryosurgical system designed to destroy tissue by applying extreme cold temperatures, which is a therapeutic function, not a diagnostic one. It is used for ablation and destruction of various tissues and lesions.
No
The device description explicitly states that the system consists of a console, single-use disposable probes, and inputs for thermocouples, all of which are hardware components.
Based on the provided information, the ENDOcare CRYOcare™ Cryosurgical System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a system designed to destroy tissue within the body by applying extreme cold temperatures. This is a therapeutic intervention performed directly on the patient.
- Device Description: The device description details a system with a console, probes, and temperature monitoring, all consistent with a surgical or therapeutic device used for tissue ablation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The ENDOcare CRYOcare™ Cryosurgical System is a therapeutic device used to treat conditions by destroying tissue in vivo.
N/A
Intended Use / Indications for Use
The ENDOcare CRYOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate, and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications:
Urology
- Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia .
Oncology
- Ablation of cancerous or malignant lissue
- Ablation of benign tumors .
- Palliative intervention
Dermatology
- Ablation or freezing of skin cancers and other cutaneous disorders .
Gynecology
- Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
General Surgery
- Destruction of warts or lesions .
- Palliation of tumors of the oral cavity, rectum and skin .
- Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell . tumors of the eyelid or canthus arca, ulcerated basal cell tumors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions
Thoracic Surgery
- Ablation of arrhythmic cardiac tissue .
- Ablation of cancerous lesions .
Proctology
- Ablation of benign or malignant growths of the anus or rectum ●
- Ablation of hemorrhoids ●
Product codes (comma separated list FDA assigned to the subject device)
OCL, GEH
Device Description
The ENDOcare CRYOcare™ Cryosuryical System consists of a console which can control one to eight single-use, disposable CR YOprobes™ and one to eight independent inputs to monitor temperatures from standard T-type needle thermocouples. The system is compact and operates off of standard 110 VAC wall power.
The system is available in 1, 4 and 8-CRYOprobetM configurations. The performance characteristics and internal design of each model are equivalent. The only differences are the number of valves to control the CRYOprobes™ (e.g., 1-8), number of thermocouple inputs (c.g., 1-8) and the size of the outer casc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, kidney, liver, skin, oral cavity, rectum, eyelid or canthus area, anus, cardiac
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.
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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).
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§ 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.
0
APR 1 0 1998
980110
Section II - SMDA 1990 Requirements
Safety and Effectiveness Summary
Device Description
The ENDOcare CRYOcare™ Cryosuryical System consists of a console which can control one to eight single-use, disposable CR YOprobes™ and one to eight independent inputs to monitor temperatures from standard T-type needle thermocouples. The system is compact and operates off of standard 110 VAC wall power.
The system is available in 1, 4 and 8-CRYOprobetM configurations. The performance characteristics and internal design of each model are equivalent. The only differences are the number of valves to control the CRYOprobes™ (e.g., 1-8), number of thermocouple inputs (c.g., 1-8) and the size of the outer casc.
Indications for Use
The ENDOcare CRYOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate, and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications:
Urology
- Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia .
Oncology
- . Ablation of cancerous or malignant tissue
- Ablation of benign tumors .
- . Palliative intervention
Dermatology
- . Ablation or freezing of skin cancers and other cutaneous disorders
Gynecology
- Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
1
$$\mathbb{X}^{\bullet} \otimes_{\mathbb{A}} \mathcal{O} \upharpoonright_{\mathcal{O}} \mathbb{Y}^{\bullet}$$
General Surgery
- Destruction of warts or lesions .
- Palliation of tumors of the oral cavity, rectum and skin .
- Ablation of leukoplakia of the mouth, angjomas, sebaceous hyperplasia, basal cell . turnors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions
Thoracic Surgery
- Ablation of arrhythmic cardiac lissue .
- Ablation of cancerous lesions t
Prociology
- Ablation of benign or malignant growths of the anus or rectum .
- Ablation of hemorrhoids .
Substantial Equivalence
The F.NDOcare CRYOcare™ CRYOsurgical System is substantially equivalent to the Cryomedical Sciences. Inc. AccuProbe® models which were found to be substantially equivalent on November 21, 1997 (reference K973190) and the ENDOcare cryosurgical system which was determined to be substantially equivalent on December 22, 1997 (K973686).
Sterilization Methodology
The following sterilization information is applicable to the CRYOprobes™ only. Sterilization validation was based on the recommendations in the current AAMI (American Association for the Advancement of Medical Instrumentation) Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices A minimum Sterility Assurance Level (SAL) of $10^{-6}$ was achieved. Sterile barrier packaging consists of standard disposable medical device packaging containing a plastic film and a coated paper side. The packaging consists of a 16" x 28", straight seal, 10-59B Tyvek/Polyester (48 ga. /Polyethylene pouch. Maximum levels of EtO residuals did not exceed.
25 ppm for ethylene oxide 25 ppm for ethylene chlorohydrin 250 ppm for ethylene glycol
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Endocare, Incorporated c/o Mr. Vin Cutarelli Vice President Regulatroy Affairs & Quality Assurance 7 Studebaker Irvine, CA 92618
Re: K980110 Trade Name: ENDOcare CRYOcare™ Cryosurgical System Regulatory Class: II (two) Product Code: OCL. GEH Dated: January 9, 1998 Received: January 12, 1998
Dear Mr. Cutarelli:
This letter corrects our substantially equivalent letter of November 29, 2004.
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.
3
Page 2 - Mr. Vin Cutarelli
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
El.mee
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication For Use Statement
510(k) Number:
Device Name: ENDOcare CRYOcare™ Cryosurgical System
9801 D
The ENDOcare CR YOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate, and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications:
Urology
-
Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia .
Oncology -
. Ablation of cancerous or malignant lissue
-
Ablation of benign tumors .
-
. Palliative intervention
Dermatology
-
Ablation or freezing of skin cancers and other cutaneous disorders .
Gynecology -
Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
Concurrence of CDRH, Office of Device Evaluation (ODE):
Mark N. Melkus
for (Division Sign-Off)
mw Division of General Restorative Devices
510(k) Number
PAGE 1OF 2
K98 0110
Prescription Usc: X (Per 21 CFR 801 109)
5
Indications for Use (continued):
General Surgery
- Destruction of warts or lesions .
- Palliation of tumors of the oral cavity, rectum and skin .
- Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell . tumors of the eyelid or canthus arca, ulcerated basal cell tumors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions
Thoracic Surgery
- Ablation of arrhythmic cardiac tissue .
- Ablation of cancerous lesions .
Prociology
- Ablation of benign or malignant growths of the anus or rectum ●
- Ablation of hemorrhoids ●
Concurrence of CDRH, Office of Device Evaluation (ODE):
Prescription Use: X (Per 21 CFR 801.109)
Murk A. Milberser
(Division Sign-Off)
for
mw Division of General Restorative Devices
510(k) Number K980110