ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES

K051509 · Erbe USA, Inc. · GEH · Jul 27, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051509
• Device Name: ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
• Applicant: Erbe USA, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jul 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ERBE ERBOKRYO® CA Cryosurgical Unit and accessories are intended for the devitalization (destruction) of tissue during surgical procedures by the application of extreme cold and for removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion.

Device Story

Cryosurgical unit applies extreme cold to tissue via Joule-Thomson effect using nitrous oxide (N2O) or carbon dioxide (CO2) gas. System consists of control unit and reusable cryoprobes. Used by physicians in clinical/surgical settings for tissue devitalization (destruction) or cryoadhesion (removal of foreign bodies, mucous plugs, necrotic tissue, or biopsy). Output is localized freezing of target tissue. Clinical benefit includes palliative treatment of tumors, recanalization of stenotic airways, and removal of obstructions. Device modifications include updated probe materials and addition of internal gas outlet filter.

Clinical Evidence

No new clinical trials conducted. Evidence provided via literature review and clinical documentation supporting the safety and efficacy of cryosurgical units for the expanded indications. Studies indicate cryotherapy is a safe, well-tolerated procedure for tracheobronchial obstruction and palliative tumor treatment, with clinical improvement in symptoms observed. Bench testing verified design modifications.

Technological Characteristics

Cryosurgical unit utilizing Joule-Thomson effect for cooling. Compatible with N2O or CO2 gas. Features reusable cryoprobes and an internal gas outlet filter compliant with ASTM standards. Biocompatible materials used in probe construction. Standalone device.

Indications for Use

Indicated for patients requiring cryosurgical intervention for conditions including: Gynecology (cervical erosions/polyps, condylomas, cervicitis, vulva carcinoma, neoplasia); Dermatology (leukoplakia, fibroma, condylomas, basal cell carcinoma, skin tumors, warts, naephus); Ophthalmology (ablatio retinae, glaucoma, lid tumor); ENT (leukoplakia, inoperable tumors, laryngeal papilloma, fibroma, angioma, haemangioma); Thoracic Surgery (post-operative); Urology (prostate/penile tumors, condylomas); Phlebology (varicose veins); Proctology (hemorrhoids, anal/rectal tumors, anal fissures); Pulmonology (tumors, granulomatous tissue, malignant lesions); and Pneumology (tracheobronchial stenoses).

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

• ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories (K934261)

Submission Summary (Full Text)

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# JUL 2 7 2005 510K SUMMARY

ERBE USA, Inc. Submitted By: 2225 Northwest Parkway Marietta, GA 30067

> Tel: [phone] Fax: [phone]

- Julie Stephens, President/Consultant Contact Person: Regulatory Resources Group, Inc.
May 31, 2005 Date Prepared:

Cryosurgical Unit and Accessories Common Name:

ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories Trade/Proprietary Name:

Unit, Cryosurgical, Accessories (21 CFR 878.4350) Classification Name:

GEH. FAZ Product Code:

Legally Marketed Predicate Device: ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories - 510(k) Number: K934261

### Device Description:

The ERBE USA, Inc. ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories is used to apply extreme cold to tissue during surgical procedures. It uses the Jouleused to apply extreme oold to toose aumy and Thompson principle where probe tip and the surrounding tissue. a fapid drop in temperature and frous Oxide) or CO2 (Carbon Dioxide) gas. The The unit is ascu with older 1120 (11) in the cryo probes are reusable and urnt and accessones are provided new surgical probes are provided in the Notes for Use.

#### Intended Use:

The ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories are intended for The ENDE ENDE ENDE of tissue during surgical procedures by the application of devitalization (dootraction) of about bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion. Also see Clinical Indications.

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## 510K SUMMARY

Similarities and Differences of the Modified Device to the Current Device (Predicate Comparison/Substantial Equivalence):

#### Similarities

The ERBE USA, Inc. ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories The ERBE USA, Inc. ENDE ENDORATE is to induce extreme cold to tissue as has the same basic technology oncreens and the indications for use are the same except for the additions noted below under differences.

The ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories has the same The ERBE ERBORINTO "OA Oryosary.car only submission # K934261 which are as follows:

"For use with nitrous oxide (N₂O) or carbon dioxide (CO₂) and cryoprobes for cryosurgery."

"Clinical Indications:

Call indications.
Gynecology - Cervical erosions, Cervical polyps, Condylomas, Chronic Cervicitis, Vulva Carcinoma (palliative), Neoplasia

Dermatology - Leukopłakia, Fibroma, Condylomas, Basal Cell Carcinoma, Skin Tumor (palliative), Warts, Naephus

Ablatio Retinae, Glaucoma, Lid Tumor Ophthalmology

ENT - Leukoplakia, Inoperable Tumor (palliative), Laryngeal Papilloma, Fibroma, Angioma, Haemangioma

Thoracic Surgery - Post-Operative

Urology - Prostate Tumor (palliative), Condylomas, Penile Tumor (palliative)

Phiebology - Varicose Veins of the Lower Limbs (Cryo Stripping)

Proctology - Hemorrhoids (1st and 2nd Degree), Pari-Anal Condylomas, Anal Tumor (palliative), Rectal Tumor (palliative), Acute Anal Fissures

Pulmonology - Tumors, Granulomatous Tissue, Malignant Lesions (palliative)

#### Differences

The ERBE USA, Inc. ERBE ÉRBOKRYO® CA Cryosurgical probe (cryo probe) utilizes different materials from the predicate; however, the materials are biocompatible [see Section III, Declaration of Conformance with Consensus Standards] The ERBE USA, Inc. ERBE ERBOKRYO® CA Cryosvrgcal unit has an added internal filter at the gas outlet in order to comply with the ASTM standard.

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### 510K SUMMARY

The ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories have and The ERBE ERBORNTO - OA STYSTYSTYCE
expanded the indications for use. The difference to the indication is:

- 1. The addition of "for removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion."
- Tracheobronchial Stenoses of addition 2. The (Cryorecanalization)"

All the ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories modifications were verified or validated in design control.

#### Conclusion:

The modifications to the ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories The modifications to the ERDC LRDORN of St. or set and were "himmal" and ormance with Consensus Standards".

All available/known studies involving "cryosurgical units" in conjunction with the All available/Known studies involving "crysuright" atthis submission. The Clinical expanded indications for use have been provided in espany of consisted documentation provided demonstrates than the Erively to remove foreign bodies (i.e., Unit and Accessones can be used surely and charges plugs, etc.) and tissue biopsy food such as peanuts, chicken bones, count, phile, has at the system can be used in by cryoadhesion. The documentation and Showsicians consider cryotherapy to be Pheumology for Tracheobronial Occhoooe. The physicalism at the end a sate procedure for the treather. Of brononial in symptoms at the end of
Patients tolerate the procedure well and show improvement in sympthassy, in a Pattents tolerate the procedure with malignant tumors that crycherapy is a the procedure. They also determinou with Thange Cases, and overally and over Mach palliative treathern in these cases, and of obstruction >50% or not). Most of and 80% measuring performance onceral (romover cryotherapy has a delayed effect in the studies did add the warning that because organ will be used as emergency treatment in acute respiratory distress.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 7 2005

ERBE USA, Inc. c/o Ms. Julie Stephens Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K051509

KUJ1509
Trade/Device Name: ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: June 2, 2005 Received: June 9, 2005

Dear Ms. Stephens:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We nave reviewed your becaon 910(t) premained is substantially equivalent (for the indications referenced above and nave uctchimed the aerrooms and devices marketed in interstate for use stated in the encrosuly manatinent date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1770, the enaement and of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMAA devices that have been recialsmed in accordance while approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the and Cosment AC. (Act) that do not require appro the general controls provisions of the Act. The You may, merelore, market the devices, becycer of the set include registration, listing of general controls provisions of the Fist 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 II your device is classified (Sec above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major and contribution may be subject to such additional controller Entisting may in 1998. In addition, FDA may be found in the Code of I subtal suggerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that 1 Dr. 5 issualite of a device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or any rederal statutes and regulations daminding, but not limited to: registration and listing (21 Comply with an the Act 31equirements, 01 ); good manufacturing practice requirements as set and CFK Fart 807), labeling (21 CFR Part 820), good if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 5 0 locs) This letter will anow you to begin marketing your antial equivalence of your device to a legally premitsel notheadon: The PDA miang of backation 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 If you desire specific advice for your do not the car as a same and the regulation entitled, and Colliact the Office of Compilance w (21 trip Part 807.97). You may obtain Misoranding by releveloc to promantonitiities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark N Millan

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): KOS/509

Device Name: ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories

Indications For Use:

The ERBE ERBOKRYO® CA Cryosurgical Unit and accessories are intended for The ERBE ERBOKKYO CA Clydsuring surgical procedures by the application of extreme
devitalization (destnuction) of tissue during surgical procedures by devitalization (destruction) of tissue during surgical procedules of the ppp
cold and for removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion.

Clinical Indications for Cryosurgery

| Gynecology | Cervical Erosions, Cervical Polyps, Condylomas, Chronic Cervicitis, Vulva<br>Carcinoma (palliative), Neoplasia |
|------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Dermatology | Leukoplakia, Fibroma, Condylomas, Basal Cell Carcinoma, Skin Tumor<br>(palliative), Warts, Naephus |
| Ophthalmology | Ablatio Retinae, Glaucoma, Lid Tumor |
| ENT | Leukoplakia, Inoperable Tumor (palliative), Laryngeal Papilloma, Fibroma,<br>Angioma, Haemangioma |
| Thoracic Surgery | Post-Operative |
| Urology | Prostate Tumor (palliative), Condylomas, Penile Tumor (palliative) |
| Phlebology | Varicose Veins of the Lower Limbs (Cryo Stripping) |
| Proctology | Hemorrhoids (1st and 2nd Degree), Pari-Anal Condylomas, Anal Tumor<br>(palliative), Rectal Tumor (palliative), Acute Anal Fissures |
| Pulmonology | Tumors, Granulomatous Tissue, Malignant Lesions (palliative) |
| Pneumology | Tracheobronchial Stenoses (Cryorecanalization) |

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Millman

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(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K05