CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1

K012497 · Galil Medical , Ltd. · GEH · Oct 30, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012497
• Device Name: CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
• Applicant: Galil Medical , Ltd.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Oct 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CRYO-HIT™ System is intended for cryogenic destruction of tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. 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. The CRYO-HIT™ System has the following specific indications: Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH") Oncology (ablation of cancerous or malignant tissue and benign tumors and palliative intervention) Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin) Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.) ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions) Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids) The CRYO-HIT™ System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.

Device Story

Cryosurgical system using extreme cold to destroy targeted tissue; utilizes argon gas for freezing. System includes console and various probes, including a 4.5 mm surface probe. Operated by physicians in clinical/surgical settings; may be used with MRI or ultrasound for real-time visualization. Provides localized tissue ablation or cryoanalgesia. Benefits include minimally invasive destruction of malignant/benign growths and pain management. Healthcare providers use visual guidance to position probes; output is physical tissue destruction via thermal application.

Clinical Evidence

Clinical evidence provided via two studies. Study 1: 48 patients, MRI-guided percutaneous cryotherapy for facet joint syndrome; 88% of pure facet syndrome patients showed 72% improvement in VAS scores. Study 2: 28 patients, intercostal cryoanalgesia following MIDCAB; 68% reported mild pain, 32% no pain at discharge, no serious side effects. Both studies demonstrate safety and efficacy.

Technological Characteristics

Cryosurgical unit using argon gas for cooling. Features console and interchangeable probes (including 4.5 mm surface probe). Compatible with MRI and ultrasound for visualization. Class II device.

Indications for Use

Indicated for patients requiring cryogenic tissue destruction across general surgery, dermatology, neurology (cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. Specific conditions include prostate cancer, BPH, malignant/benign tumors, skin lesions, warts, gynecological dysplasia, and cardiac arrhythmias. No specific contraindications listed.

Regulatory Classification

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.

Predicate Devices

• CRYO-HIT™ (K993965)
• Cryomedics, Neurostat
• Spembly Lloyd Neurostat

Submission Summary (Full Text)

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OCT 3 0 2001

#### Attachment 3

# Section 8-510(k) Summary

#### 510(k) Summary

Galil Medical - Cryo-Hit™ System

510(k) Number K012497

Company Name:

Galil Medical Ltd.

#### Contact Person:

Dr. Roni Zvuloni, Director of IP & Regulatory Affairs Telephone: [phone] Fax: [phone]

Trade Proprietary Name: Cryo-HitTM

Classification Name: CRYOSURGICAL UNIT

Classification: GEH

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#### Predicate Devices:

- 1. CRYO-HIT™
- 2. Cryomedics, Neurostat
- 3. Spembly Lloyd Neurostat

### Indication for Use:

The CRYO-HIT™ System is intended for cryogenic destruction of tissue during surgical procedures.

It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology.

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.

The CRYO-HIT™ System has the following specific indications:

Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")

Oncology (ablation of cancerous or malignant tissue and benign tumors and palliative intervention)

Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin)

Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)

General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.)

ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth)

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Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions)

Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

The CRYO-HIT™ System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.

#### Technological Characteristics:

The Galil Medical's Cryo-Hit™ System for Cryoanalgesia is a modification of Galil Medical LTD's cleared Cryo-Hit™ (K993965). The modified Cryo-Hit™ System is the exact same device as the Cryo-Hit™ except for the addition of the 4.5 mm surface probe.

#### Performance Data:

The medical literature discusses the use of cryoanalgesia at least as early as 1976. FDA cleared Spembly's Neurostat for cryoanalgesia two years later. The medical literature contains data regarding hundreds of successful cryoanalgesia treatments. Thus, cryoanalgesia has a long history of safe and effective use.

Galil Medical presented two recent studies regarding the Cryo-Hit for Cryoanalgesia.

| Article | MRI Guided Percutaneous<br>Cryotherapy of the Facet Joint<br>Syndrome- Clinical<br>Results with up to Two Years of<br>Follow Up | Successful treatment of post-operative<br>pain with Intercostal Cryoanalgesia<br>following MIDCAB for coronary<br>revascularization |
|-------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Author | J.F. ROY et al. | JD Fonger et al |
| Journal | Abstract for THE ISMR 9(2001) | TO BE SUBMITTED FOR<br>PUBLICATION |
| Patient No. | 48 | 28 |

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| Patients<br>that<br>received<br>Cryoanalge<br>sia | 48 | 28 |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The<br>Cryoanalge<br>sia<br>Apparatus | CRYO-HITTM | CRYO-HITTM |
| Gas used<br>for freezing | Argon | Argon |
| Probe --<br>diameter | 3mm blunt | 4.5 mm surface |
| Monitoring<br>method | MRI | Direct visualization of the Nerve<br>Bundle |
| Median<br>analgesia<br>Period | 11.4 months | Not reported |
| Complicati<br>ons | No major complications | No major complications |
| Study<br>results | The VAS score for<br>88% of patients with a pure facet<br>syndrome improved by an average<br>of 72%. The VAS score of 53% of<br>patients with discopathy 53% of<br>improved by 39%. Patients with<br>spinal fusion had a little<br>improvement in their lower back<br>pain. | None of the patients needed additional<br>treatment. 62% had a mean pain score <<br>4 (mild pain), 31% had a mean pain score<br>between 4 through 7 (moderate pain), and<br>only 7% of the patients suffered from<br>severe pain based on their VAS scores<br>Based on a post-operative Visual<br>Analogue Scale, 32% of the patients had<br>no pain at all upon discharge, and 68%<br>had only mild pain that could be treated<br>easily with OTC drugs.<br>None of the patients suffered any serious<br>side effects or needed any additional<br>intervention. |
| Conclusion | This study demonstrates the<br>Cryo-Hit's safety and efficacy for<br>administering cryoanalgesia in<br>treatment of facet joint syndrome. | The results show that the Cryo-Hit can<br>successfully perform Intercostal<br>Cryoanalgesia. |

These studies show that the Cryo-Hit for Cyroanalgesia is as safe and effective as the predicate devices for cryoanalgesia.

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# Substantial Equivalence:

The Cryo-Hit for Cryoanalgesia has the same intended use as the cleared CRYO-HIT™ System, the cleared Cryomedics Neurostat, and the cleared Spembly Lloyd Neurostat. The Cryo-Hit for Cryoanalgesia has the same general and specific indications as a combination of these predicate devices. In addition, the Cryo-Hit is the exact same device as the cleared Cryo-Hit except for the addition of a modified probe as an accessory. The modified probe does not raise any new questions of safety or effectiveness. The other technological differences between the Cryo-Hit for cryoanalgesia and the Neurostat devices also do not raise any new questions of safety or effectiveness for this indication. Moreover, clinical data demonstrates that the Cryo-Hit for Cryoanalgesia is as safe and effective as the predicate devices for this indication. Thus, the Cryo-Hit for Cryoanalgesia is substantially equivalent.

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Public Health Service

Image /page/5/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Galil Medical Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004

Re: K012497

Trade/Device Name: Cryo-Hit™ System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH Dated: August 3. 2001 Received: August 3, 2001

Dear Mr. Kahan:

This letter corrects our substantially equivalent letter of October 30, 2001.

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.

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Page 2 - Mr. Jonathan S. Kahan

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.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

el.9mple

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Attachment 2

# SECTION 9-INDICATIONS FOR USE

## INDICATIONS FOR USE

510(k) Number (if known):

K012497

Device Name:

Cryo-Hit™ System

Indications for Use:

The CRYO-HIT™ System is intended for cryogenic destruction of tissue during surgical procedures.

It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology.

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.

The CRYO-HIT™ System has the following specific indications:

Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")

Oncology (ablation of cancerous or malignant tissue and benign tumors and palliative intervention)

Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the evelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous

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hemanglomas, perianal condylomata, and palliation of tumors of the skin)

Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)

General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.)

ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth)

Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions)

Proctology (ablation of benign or malignant growths of the anus or rectum and hemorrhoids)

The CRYO-HIT™ System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.

# (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE) (Division Sign-off) Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices

510(k) Number

11 OR Prescription Use (Per 21 CFR 801.109)

Sasa Wal

(Division Sign-Off) Dover the Country Restorative ands eurological Devices

510(k) Number K012497