D.O.R.C. Disposable Cryo Probe

K160591 · Dutch Ophthalmic Research Center International BV · HRN · Jan 23, 2017 · Ophthalmic

Device Facts

• Record ID: K160591
• Device Name: D.O.R.C. Disposable Cryo Probe
• Applicant: Dutch Ophthalmic Research Center International BV
• Product Code: HRN · Ophthalmic
• Decision Date: Jan 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4170
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior or anterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.

Device Story

Single-use, handheld cryophthalmic probe; used with Cryostar Cryosurgical System. Input: high-pressure CO2 or N2O gas. Operation: rapid gas expansion via Joule-Thompson principle creates freezing effect at stainless steel tip. Output: localized ice ball for tissue destruction/adhesion. Used in ophthalmic surgery; operated by physician via system footswitch. Benefits: provides sterile, disposable alternative to reusable probes; eliminates reprocessing requirements; maintains equivalent freeze/defrost performance to predicate.

Clinical Evidence

Bench testing only. No clinical or animal data required. Performance testing verified freeze/defrost capabilities: average ice ball diameter of 4.9mm after 10s operation; defrost within 5s. Compatibility with Cryostar 1500.III system confirmed.

Technological Characteristics

Stainless steel tip; acetal handle; flexible nylon exhaust tube. Energy source: high-pressure CO2 or N2O gas. Joule-Thompson cooling principle. Dimensions: 2.5mm tip diameter, 136.3mm length. Sterilization: Ethylene Oxide. Standards: ISO 10993 (biocompatibility), ISO 11135 (sterilization), ISO 11607 (packaging), EN 62366 (usability).

Indications for Use

Indicated for ophthalmic surgery of posterior or anterior segments, including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retinopathy of prematurity in patients requiring cryosurgical intervention.

Regulatory Classification

Identification

A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.

Predicate Devices

• Cryostar Cryosurgical System Reusable Cryo Probe (K012821)
• Cryomatic Disposable Cryo Probes (K131787)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 23, 2017

Dutch Ophthalmic Research Center International BV Ms. Linda van Leeuwen Manager Regulatory Affairs Scheijdelveweg 2 Zuidland, 3214 VN The Netherlands

Re: K160591

Trade/Device Name: D.O.R.C. Disposable Cryo Probe Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic Unit Regulatory Class: Class II Product Code: HRN Dated: November 29, 2016 Received: December 21, 2016

Dear Ms. van Leeuwen:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological H

Enclosure

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# Indications for Use

510(k) Number (if known) K160591

Device Name D.O.R.C. Disposable Cryo Probe

#### Indications for Use (Describe)

The D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.

Type of Use (Select one or both, as applicable)

| <span></span> | <span></span> |
|----------------------------------------------|---------------|
| <div></div> | <div></div> |
| Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div></div> |

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### 510(K) SUMMARY

This summary is in accordance with 21 CFR 807.92.

#### Submitter

The submitter of the 510(k) is:

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Scheijdelveweg 2 3214 VN Zuidland The Netherlands

Contact person: Mrs. Daniëlle Sleegers, Manager Regulatory Affairs Phone: [phone] Email: RAUSA&[e-mail]

Date Prepared: January 20th, 2017

### Device

Device Subject to this 510(k):

| Trade Name: | D.O.R.C. Disposable Cryo Probe |
|----------------------|--------------------------------------------------------|
| Common Name: | Cryophthalmic Probe |
| Classification: | II |
| Classification Name: | Cryophthalmic unit (21 CFR 886.4170, Product Code HRN) |

The following regulations are applicable for this 510(k):

- 21 CFR 886.4170 Cryophthalmic unit ●
### Predicate Devices

| 510(k) Number | Device |
|---------------|-------------------------------------------------------------|
| K012821 | Cryostar Cryosurgical System Reusable Cryo Probe (D.O.R.C.) |
| K131787 | Cryomatic Disposable Cryo Probes (Keeler Ltd.) |

### Device Description

The D.O.R.C. Disposable Cryo Probe is a single-use, handheld medical device intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery. When the foot pedal of the CryoStar Console is pressed, high pressure gas (CO2 or N2O) is supplied via a small aperture to target tissue.

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# Indications for Use

The D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior or anterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.

# Comparison of Technological Characteristics with the Predicate Devices

There are no technological characteristics or features of the D.O.R.C. Disposable Cryo Probe that have not been previously cleared in predicate devices as is shown in the following table.

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| Description | Proposed Device -<br>Disposable Cryo Probe<br>(D.O.R.C.) | Cryostar Cryosurgical System<br>Reusable Cryo Probe<br>(D.O.R.C.) | Cryomatic Disposable Cryo<br>Probes<br>(Keeler Ltd.) |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| 510(k) # | K160591 | K012821 | K131787 |
| Product<br>Code(s) | HRN | HRN | HRN |
| Intended<br>Uses | Cryophthalmic surgery | Cryophthalmic surgery | Cryophthalmic surgery |
| Cryogen Gas<br>Delivered | Nitrous Oxide and Carbon Dioxide | Nitrous Oxide and Carbon Dioxide | Nitrous Oxide and Carbon Dioxide |
| Method of<br>Operation | Rapid expansion of cryogenic gas<br>causes a freezing effect according<br>to the Joule-Thompson principle | Rapid expansion of cryogenic gas<br>causes a freezing effect according<br>to the Joule-Thompson principle | Rapid expansion of cryogenic gas<br>causes a freezing effect according<br>to the Joule-Thompson principle |
| Freeze Rate | After 10s operation an ice ball<br>diameter shall be at least 4mm<br>when immersed 2mm in water of<br>20°C with both CO2 and N₂O | After 10s operation an ice ball<br>diameter shall be at least 4mm<br>when immersed 2mm in water of<br>20°C with both CO2 and N2O | Unknown |
| Defrost Rate | Within 5s the ice ball of at least<br>4mm shall be released when<br>defrost function is activated with<br>both CO2 and N₂O | Within 5s the ice ball of at least<br>4mm shall be released when<br>defrost function is activated with<br>both CO2 and N2O | Unknown |
| Compatible<br>with System | Cryostar 1500.III (K012821) | Cryostar 1500.III (K012821) | Cryomatic MKII (K131787) |
| Control<br>Mechanism | Footswitch of Cryostar | Footswitch of Cryostar | Footswitch of Cryomatic MKII |
| Single Use | Yes | No (Reusable) | Yes |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Tip Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Handle<br>Material | Acetal | Aluminum | Metal (Unknown) |
| Supply Tube | Stainless Steel | Flexible plastic | High-pressure plastic |
| Exhaust<br>Tube | Flexible Nylon | Flexible plastic | Unknown |
| Tip Outer<br>Diameter,<br>Geometry | 2.5 mm, angled | 2.5 mm, angled | Unknown |
| Length<br>(Handpiece<br>and Tip) | 5.4 inches (136,3 mm) | 5.9 inches (150 mm) | Unknown |
| Total Weight | 58 grams | 328 grams | Unknown |
| Packaging | Peel Pouch | Peel Pouch | |

# Comparison of Features of the D.O.R.C. Disposable Cryo Probe and Predicate Devices

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### Performance Data

The following performance data were provided in support of the substantial equivalence determination.

### Biocompatibility testing

The biocompatibility evaluation of the D.O.R.C. Disposable Cryo Probe was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

#### Performance Testing

Although animal and clinical performance testing was not required for the D.O.R.C. Disposable Cryo Probe to demonstrate efficacy, safety and substantial equivalence to predicate devices, a variety of laboratory (bench) performance tests have been conducted including freeze and defrost performance and compatibility testing with the Cryostar 1500.III Cryosurgical System. The 'freeze performance' test showed that both the Disposable Cryo Probe (1540.D) and the Reusable Cryoprobe (1540) produced an ice ball of on average 4.9mm after 10s operation when immersed in water of 20℃ with both CO2 and N20. The 'defrost performance' test showed that both the Disposable Cryo Probe (1540.D) and the Reusable Cryoprobe (1540) released the ice ball of at least 4mm within 5s after activation of the defrost function with both CO2 and N2O. Therefore it was concluded that the Disposable Cryoprobe (1540.D) is equivalent to the Reusable Cryoprobe (1540). Both the 'freeze performance' test and the 'defrost performance' test were performed using the Cryostar (1500.III), showing the compatibility of the Disposable Cryoprobe (1540.D) with this Cryosurgical System.

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| Standard # | Title |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EN ISO 10993-<br>1:2009/AC:2010 | Biological Evaluation Of Medical Devices -- Part 1: Evaluation And<br>Testing |
| EN ISO 10993-5:<br>2009 | Biological Evaluation Of Medical Devices -- Part 5: Tests For In<br>Vitro Cytotoxicity |
| EN ISO 10993-7:<br>2008/AC:2009 | Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide<br>Sterilization Residuals |
| EN ISO 10993-10:<br>2010 | Biological Evaluation Of Medical Devices - Part 10: Tests For<br>Irritation And Sensitization |
| ISO 10993-12: 2012 | Biological Evaluation Of Medical Devices - Part 12: Sample<br>Preparation and Reference Materials |
| ISO 11135-1:2007 | Sterilization Of Health-Care Products - Ethylene Oxide – Part 1:<br>Requirements for the Development, Validation and Routine Control<br>of a Sterilization Process for Medical Devices |
| EN ISO 14971:2012 | Medical Devices: Application Of Risk Management To Medical<br>Devices |
| ISO 11607-1:2009 | Packaging For Terminally Sterilized Medical Devices - Part 1:<br>Requirements For Materials, Sterile Barrier Systems And Packaging<br>Systems |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices - Part 2:<br>Validation requirements for forming, sealing and assembly processes |
| ISO 15223-1:2012 | Medical devices - Symbols to be used with medical device labels,<br>labelling and information to be supplied - Part 1: General<br>requirements |
| ASTM D4169-14 | Practice for performance testing of shipping containers and systems<br>Practice for performance testing of shipping containers and systems |
| EN 62366:2008 | Medical devices - Application of usability engineering to medical<br>devices |

The device will comply with applicable sections of the following standards:

# Conclusion

The information presented in this 510(k) premarket notification demonstrates that the

D.O.R.C. Disposable Cryo Probe is substantially equivalent to the legally marketed predicate devices.