(88 days)
CRYO-HIT™, Neurostat, Spembly Lloyd Neurostat
There are no Reference Devices listed in the provided text.
No
The summary describes a cryosurgical system for tissue destruction using extreme cold. There is no mention of AI, ML, or any computational analysis of imaging or other data to guide the procedure or predict outcomes. The device description focuses on the physical components and intended use.
Yes
The device is intended for the destruction of tissue during surgical procedures to treat various medical conditions, which aligns with the definition of a therapeutic device.
No
The CRYO-HIT™ System is intended for tissue destruction through cryosurgical procedures, not for identifying or characterizing diseases. While it can be used with imaging for visualization, its primary function is therapeutic (ablation), not diagnostic.
No
The device description explicitly states it is a "System" and a "modification of Galil Medical LTD's cleared Cryo-Hit™ (K993965)". The intended use describes "cryogenic destruction of tissue during surgical procedures" and the application of "extreme cold temperatures," which inherently requires hardware components to generate and deliver the cold. The description also mentions the addition of a "4.5 mm surface probe," which is a physical hardware component. Therefore, this is not a software-only medical device.
Based on the provided information, the CRYO-HIT™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "cryogenic destruction of tissue during surgical procedures." This is a direct therapeutic intervention performed on the patient's body.
- Device Description: The device is described as a "Cryo-Hit™ System for Cryoanalgesia," which is a tool used in surgery.
- Mechanism of Action: The system works by applying extreme cold temperatures to destroy tissue. This is a physical process applied directly to the patient.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The CRYO-HIT™ System does not perform any such analysis on specimens.
The CRYO-HIT™ System is a surgical device used for therapeutic purposes (tissue destruction and pain relief through cryoanalgesia). While it may be used with imaging modalities like MRI or ultrasound for guidance during the procedure, these are tools to assist the surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / 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 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.
Product codes
OCL, GEH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging (MRI) device or an ultrasound device
Anatomical Site
prostate and kidney tissue, liver, skin, prostate, cancerous or malignant tissue, benign tumors, skin cancers, cutaneous disorders, warts, 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, tumors of the skin, malignant neoplasia or benign dysplasia of the female genitalia, tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, recurrent cancerous lesions, tumors of the oral cavity, leukoplakia of the mouth, arrhythmic cardiac tissue, cancerous lesions, benign or malignant growths of the anus or rectum, hemorrhoids.
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)
Two studies regarding the Cryo-Hit for Cryoanalgesia were presented.
Study 1: MRI Guided Percutaneous Cryotherapy of the Facet Joint Syndrome- Clinical Results with up to Two Years of Follow Up
- Author: J.F. ROY et al.
- Journal: Abstract for THE ISMR 9(2001)
- Patient No.: 48 patients received Cryoanalgesia.
- Cryoanalgesia Apparatus: CRYO-HIT™
- Gas used for freezing: Argon
- Probe -- diameter: 3mm blunt
- Monitoring method: MRI
- Median analgesia Period: 11.4 months
- Complications: No major complications
- Study results: The VAS score for 88% of patients with a pure facet syndrome improved by an average of 72%. The VAS score of 53% of patients with discopathy improved by 39%. Patients with spinal fusion had a little improvement in their lower back pain.
- Conclusion: This study demonstrates the Cryo-Hit's safety and efficacy for administering cryoanalgesia in treatment of facet joint syndrome.
Study 2: Successful treatment of post-operative pain with Intercostal Cryoanalgesia following MIDCAB for coronary revascularization
- Author: JD Fonger et al
- Journal: TO BE SUBMITTED FOR PUBLICATION
- Patient No.: 28 patients received Cryoanalgesia.
- Cryoanalgesia Apparatus: CRYO-HIT™
- Gas used for freezing: Argon
- Probe -- diameter: 4.5 mm surface
- Monitoring method: Direct visualization of the Nerve Bundle
- Median analgesia Period: Not reported
- Complications: No major complications
- Study results: None of the patients needed additional treatment. 62% had a mean pain score
§ 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
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
1
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)
2
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
Cryotherapy of the Facet Joint
Syndrome- Clinical
Results with up to Two Years of
Follow Up | Successful treatment of post-operative
pain with Intercostal Cryoanalgesia
following MIDCAB for coronary
revascularization |
|-------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Author | J.F. ROY et al. | JD Fonger et al |
| Journal | Abstract for THE ISMR 9(2001) | TO BE SUBMITTED FOR
PUBLICATION |
| Patient No. | 48 | 28 |
3
| Patients
that
received
Cryoanalge
| sia | 48 | 28 |
|---|---|---|
| The | ||
| Cryoanalge | ||
| sia | ||
| Apparatus | CRYO-HITTM | CRYO-HITTM |
| Gas used | ||
| for freezing | Argon | Argon |
| Probe -- | ||
| diameter | 3mm blunt | 4.5 mm surface |
| Monitoring | ||
| method | MRI | Direct visualization of the Nerve |
| Bundle | ||
| Median | ||
| analgesia | ||
| Period | 11.4 months | Not reported |
| Complicati | ||
| ons | No major complications | No major complications |
| Study | ||
| results | The VAS score for | |
| 88% of patients with a pure facet | ||
| syndrome improved by an average | ||
| of 72%. The VAS score of 53% of | ||
| patients with discopathy 53% of | ||
| improved by 39%. Patients with | ||
| spinal fusion had a little | ||
| improvement in their lower back | ||
| pain. | None of the patients needed additional | |
| treatment. 62% had a mean pain score |