(88 days)
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.
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.
The provided document is a 510(k) summary for the Galil Medical Cryo-Hit™ System, focusing on a modification for cryoanalgesia. It does not present specific acceptance criteria or a formal study designed to "prove the device meets acceptance criteria" in the way one would expect for a diagnostic or AI-driven medical device. Instead, it relies on demonstrating substantial equivalence to predicate devices and referencing existing medical literature and two clinical studies to support the safety and effectiveness of the device for cryoanalgesia.
Therefore, many of the requested elements (like a table of acceptance criteria, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or standalone performance) are not applicable or explicitly stated in this type of regulatory submission for a simple device modification.
Below is an attempt to address the requested information based on what is available in the document, with explicit notes about what is not provided.
Description of Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria
The Galil Medical Cryo-Hit™ System is a cryosurgical unit. The specific submission is for a modification focusing on its use for cryoanalgesia, with the addition of a 4.5 mm surface probe. The acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices by showing the modified device is as safe and effective for its intended use.
The study supporting this claim consists of reviewing existing medical literature on cryoanalgesia and presenting two recent clinical studies conducted using the Cryo-Hit™ system.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a cryosurgical unit modification and not a diagnostic device, explicit "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, etc.) are not defined. Instead, the "acceptance" is based on demonstrating safety and effectiveness compared to predicate devices for the specified indications. The reported device performance is described in terms of clinical outcomes, primarily pain reduction and absence of major complications.
| Feature / Outcome | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Safety | No new questions of safety compared to predicate devices. Absence of major complications. | Study 1 (Facet Joint): No major complications reported. Study 2 (Intercostal Cryoanalgesia): No major complications or serious side effects. No additional intervention needed. |
| Effectiveness (Pain Reduction - Facet Joint) | Comparable or improved pain relief to established cryoanalgesia methods. | Study 1: VAS score for 88% of patients with pure facet syndrome improved by an average of 72%. VAS score of 53% of patients with discopathy improved by 39%. Patients with spinal fusion had little improvement. Median analgesia period: 11.4 months. |
| Effectiveness (Pain Reduction - Post-Op Chest) | Comparable or improved pain relief for post-operative pain to established cryoanalgesia methods. | Study 2: 62% had a mean pain score < 4 (mild pain). 31% had a mean pain score between 4-7 (moderate pain). 7% had severe pain. Upon discharge, 32% had no pain, and 68% had only mild pain treatable with OTC drugs. None needed additional treatment. |
| Technological Characteristics (Cryoanalgesia) | Device function as a cryosurgical tool for cryoanalgesia, consistent with predicate devices and prior cleared device. | Cryo-Hit™ system used with Argon gas for freezing. Probes: 3mm blunt (Study 1), 4.5mm surface (Study 2). Monitoring: MRI (Study 1), Direct visualization of Nerve Bundle (Study 2). |
| Similarity to Predicate Devices (for Cryoanalgesia) | Same intended use, comparable indications, and no new questions of safety or effectiveness from modifications. | The Cryo-Hit™ for Cryoanalgesia has the same intended use as CRYO-HIT™ (K993965), Cryomedics Neurostat, and Spembly Lloyd Neurostat. The specific indications are a combination of these predicate devices. The device is the same as the cleared Cryo-Hit™ except for the additional 4.5 mm surface probe, which does not raise new safety or effectiveness concerns. Clinical data presented aims to demonstrate equivalence in safety and effectiveness. |
2. Sample size used for the test set and the data provenance
The document presents data from two clinical studies:
- Study 1 (Facet Joint Syndrome):
- Sample Size (Patients that received Cryoanalgesia): 48
- Data Provenance: Not explicitly stated, but the author is J.F. ROY et al., abstract for "THE ISMR 9(2001)". This suggests a European or international origin, possibly for a medical conference. This is a retrospective summary of clinical results.
- Study 2 (Intercostal Cryoanalgesia):
- Sample Size (Patients that received Cryoanalgesia): 28
- Data Provenance: Not explicitly stated, but the author is JD Fonger et al., "TO BE SUBMITTED FOR PUBLICATION". This is a retrospective summary of clinical results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as the studies are clinical outcome studies, not studies requiring expert review of medical images or data for ground truth establishment. Patient pain scores (VAS) are self-reported outcomes.
4. Adjudication method for the test set
This information is not provided and is not applicable given the nature of the clinical outcome studies (patient-reported pain scores).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, especially those incorporating AI. The Cryo-Hit™ is a surgical tool, and the studies presented focus on its clinical outcomes.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The Cryo-Hit™ is a physical medical device (cryosurgical unit) operated by a clinician, not an algorithm. Therefore, "standalone performance" in the context of an algorithm without human intervention is not relevant.
7. The type of ground truth used
The "ground truth" in these clinical studies is primarily based on:
- Patient-reported outcomes: Visual Analog Scale (VAS) scores for pain.
- Clinical observation: Assessment for complications by medical professionals.
- Absence of need for additional treatment.
This is considered outcomes data and clinical assessment by the treating physicians.
8. The sample size for the training set
This information is not applicable/not provided. The Cryo-Hit™ is a hardware device; thus, it does not have a "training set" in the context of machine learning algorithms. The development and design validation would rely on engineering principles, predicate device extensive history of use, and potentially bench testing, but not a data-driven training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as #8.
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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: +972-4-959 10 80 Fax: +972-4-959 10 77
Trade Proprietary Name: Cryo-HitTM
Classification Name: CRYOSURGICAL UNIT
Classification: GEH
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Predicate Devices:
-
- CRYO-HIT™
-
- Cryomedics, Neurostat
-
- 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 PercutaneousCryotherapy of the Facet JointSyndrome- ClinicalResults with up to Two Years ofFollow Up | Successful treatment of post-operativepain with Intercostal Cryoanalgesiafollowing MIDCAB for coronaryrevascularization |
|---|---|---|
| Author | J.F. ROY et al. | JD Fonger et al |
| Journal | Abstract for THE ISMR 9(2001) | TO BE SUBMITTED FORPUBLICATION |
| Patient No. | 48 | 28 |
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| PatientsthatreceivedCryoanalgesia | 48 | 28 |
|---|---|---|
| TheCryoanalgesiaApparatus | CRYO-HITTM | CRYO-HITTM |
| Gas usedfor freezing | Argon | Argon |
| Probe --diameter | 3mm blunt | 4.5 mm surface |
| Monitoringmethod | MRI | Direct visualization of the NerveBundle |
| MediananalgesiaPeriod | 11.4 months | Not reported |
| Complications | No major complications | No major complications |
| Studyresults | The VAS score for88% of patients with a pure facetsyndrome improved by an averageof 72%. The VAS score of 53% ofpatients with discopathy 53% ofimproved by 39%. Patients withspinal fusion had a littleimprovement in their lower backpain. | None of the patients needed additionaltreatment. 62% had a mean pain score <4 (mild pain), 31% had a mean pain scorebetween 4 through 7 (moderate pain), andonly 7% of the patients suffered fromsevere pain based on their VAS scoresBased on a post-operative VisualAnalogue Scale, 32% of the patients hadno pain at all upon discharge, and 68%had only mild pain that could be treatedeasily with OTC drugs.None of the patients suffered any seriousside effects or needed any additionalintervention. |
| Conclusion | This study demonstrates theCryo-Hit's safety and efficacy foradministering cryoanalgesia intreatment of facet joint syndrome. | The results show that the Cryo-Hit cansuccessfully perform IntercostalCryoanalgesia. |
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 (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 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):
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
{8}------------------------------------------------
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
§ 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.