Codman Disposable Perforators

K183581 · Integra Lifesciences Corp. · HBF · Jan 20, 2019 · Neurology

Device Facts

• Record ID: K183581
• Device Name: Codman Disposable Perforators
• Applicant: Integra Lifesciences Corp.
• Product Code: HBF · Neurology
• Decision Date: Jan 20, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4305
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Codman Disposable Perforator is for use in perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

Device Story

Single-use, sterile, disposable cranial perforator; available in 9mm, 11mm, and 14mm sizes. Device features Hudson end for attachment to surgical drill driver. Principle of operation: mechanical engagement via pressure applied to drill point; automatic disengagement upon completion of perforation or removal of pressure. Used in neurosurgical procedures; operated by surgeons. Benefits include controlled cranial perforation and automatic disengagement to prevent unintended penetration. Device is identical to predicates except for alternate gamma irradiation sterilization cycle.

Clinical Evidence

No clinical data. Bench testing only. Validation of alternate gamma sterilization cycle performed via dose mapping study (Dose Uniformity Ratio < 2) in compliance with ISO 11137-1.

Technological Characteristics

Materials: ABS plastic (sleeve), metal components (drill body, spring, drive pin, bearing, nyliner). Energy source: mechanical (powered by external surgical drill driver). Form factor: color-coded disposable drill bits (9mm, 11mm, 14mm). Sterilization: Gamma irradiation (25kGy-50kGy, SAL 10^-6).

Indications for Use

Indicated for use in perforating the cranium.

Regulatory Classification

Identification

Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.

Predicate Devices

• Codman Disposable Perforator (14mm) (K791101)
• Codman Disposable Perforators (11mm & 9mm) (K071931)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

January 20, 2019

Integra LifeSciences Corp. Jocelyn Raposo Associate Director, Regulatory Affairs 11 Cabot Blvd Mansfield, Massachusetts 02048

Re: K183581

Trade/Device Name: Codman Disposable Perforators Regulation Number: 21 CFR 882.4305 Regulation Name: Powered Compound Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBF Dated: December 20, 2018 Received: December 21, 2018

Dear Jocelyn Raposo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Matthew C. Krueger -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | |
| K183581 | |
| Device Name | |

Codman Disposable Perforator

Indications for Use (Describe)

The Codman Disposable Perforator is for use in perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Sevices [phone] EF

{3}------------------------------------------------

## Section 5 - 510(k) Summary

| I. Submitter | Integra LifeSciences Corp.<br>11 Cabot Blvd.<br>Mansfield, MA 02048 | |
|--------------|---------------------------------------------------------------------|----------------------------------|
| | Establishment Registration Number: 1226348 | |
| | Primary Contact:<br>Phone: | Jocelyn Raposo<br>[phone] |
| | Secondary Contact:<br>Phone: | Jennifer Siu<br>[phone] |

Date of Preparation: December 19, 2018

#### II. Device(s)

| Device Proprietary Name | Codman Disposable Perforators |
|---------------------------|---------------------------------------------------------------------------------|
| Common Name | Perforators |
| Classification Name | Drills, Burrs, Trephines & Accessories<br>(Compound, Powered) (21 CFR 882.4305) |
| Regulatory Classification | II |
| Product Code | HBF |

III. Predicate

The predicate devices for this submission are:

Device(s)

The predicate devices for this submission are:

| 510(k) Number | Date Cleared | Title |
|---------------|---------------|-----------------------------------------------|
| K791101 | Aug. 28, 1979 | Codman Disposable Perforator<br>(14mm) |
| K071931 | Oct. 22, 2007 | Codman Disposable Perforators<br>(11mm & 9mm) |

IV. Device Description(s) The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. When properly used, the Disposable Perforators are designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point. They are designed with a Hudson end and are available in three color-coded sizes:

- 14mm (blue ABS sleeve) – product number: 26-1221
- 11mm (green ABS sleeve) product number: 26-1222 ●
- 9mm (yellow ABS sleeve) product number: 26-1223 ●

{4}------------------------------------------------

### V. Indications for Use

The Indications for Use statement of the proposed device remains identical to the predicate devices'.

| Equivalence<br>Comparison | Codman Disposable<br>Perforators (Predicates) | Codman Disposable<br>Perforators (Subject of This<br>Submission) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Codman Disposable<br>Perforator is for use in<br>perforating the cranium.<br>When properly used, it is<br>designed to automatically<br>disengage once perforation is<br>accomplished and when<br>pressure is removed from the<br>drill point. | The Codman Disposable<br>Perforator is for use in<br>perforating the cranium.<br>When properly used, it is<br>designed to automatically<br>disengage once perforation is<br>accomplished and when<br>pressure is removed from the<br>drill point. |

#### VI. Comparison to Predicate Device

The proposed Codman Disposable Perforators are identical to the currently marketed Codman Disposable Perforators (K791101 & K071931) except for the alternate gamma irradiation sterilization cycle proposed in this 510(k). The indications for use, design, principle of operation, performance, packaging, and shelf life remain identical to the predicate devices.

| Substantial Equivalence Comparison | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Characteristic | Codman Disposable<br>Perforators (Predicates) | Codman Disposable<br>Perforators (Subject of<br>This Submission) |
| Manufacturer | Codman & Shurtleff, Inc. | Identical |
| Classification Panel | Neurology | Identical |
| Classification Name | Drills, Burrs, Trephines &<br>Accessories (Compound,<br>Powered) (21 CFR<br>882.4305) | Identical |
| Indications for Use | The Codman Disposable<br>Perforator is for use in<br>perforating the cranium.<br>When properly used, it is<br>designed to automatically<br>disengage once<br>perforation is<br>accomplished and when<br>pressure is removed from<br>the drill point. | Identical |
| Operating Principle | With adequate pressure<br>applied on the perforator<br>point, engagement should<br>occur as the Hudson End<br>is rotated in a driver. Once<br>pressure is removed from<br>the drill point the device is<br>designed to disengage. | Identical |
| Implant | No | Identical |
| Single Use Only | Yes | Identical |

{5}------------------------------------------------

VII.

Data

Performance

| Special 510(k) Premarket Notification |
|---------------------------------------|
| Codman Disposable Perforators |

| Substantial Equivalence Comparison | | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Characteristic | Codman Disposable<br>Perforators (Predicates) | Codman Disposable<br>Perforators (Subject of<br>This Submission) |
| Design | 9 mm Perforator<br>consisting of outer and<br>inner body drill, drill<br>driver, compression<br>spring, drive pin, molded<br>sleeve, snap bearing,<br>flanged nyliner<br>11mm Perforator<br>consisting of outer and<br>inner body drill, drill<br>driver, compression<br>spring, drive pin, molded<br>sleeve, snap bearing,<br>flanged nyliner<br>14mm Perforator<br>consisting of outer and<br>inner body drill, drill<br>driver, compression<br>spring, drive pin, molded<br>sleeve, snap bearing,<br>flanged nyliner | Identical |
| Shelf Life | 5 years | Identical |
| Sterilization Method | Gamma | Identical |
| Sterility Assurance Level<br>(SAL) | 10-6 | Identical |
| Packaging | PETG Blister Tray with<br>heat-sealed lid placed into<br>a unit box | Identical |

There were no changes made that affect the Codman Disposable Perforators' indications for use, principle of operation, performance, packaging, or shelf life. The only difference between the predicate and proposed devices is the use of an alternate gamma irradiation sterilization cycle to sterilize the products. There is no change to the sterilization dose parameters (25kGy-50kGy). The products continue to meet a SAL of 10-6 with the new cycle. A full dose mapping study has been performed to ensure there are no new issues relating to the safety or effectiveness of the products.

Please see the Summary of Testing table below for acceptance criteria and testing results.

| Table Summary of Testing | | | |
|---------------------------------|------------------------------------------------------------------------------------------------|---------------------------|--------|
| Test | Test Method /<br>Purpose | Acceptance Criteria | Result |
| Full Dose Mapping<br>Validation | Establish a new<br>gamma radiation<br>sterilization cycle in<br>compliance with<br>ISO 11137-1 | Dose Uniformity Ratio: <2 | Pass |

{6}------------------------------------------------

Integra LifeSciences Codman Specialty Surgical Special 510(k) Premarket Notification Codman Disposable Perforators

#### Animal Testing:

No animal studies were required based on similarities of the proposed device to the predicate device and from the results of the sterilization validation.

### Clinical Testing:

No clinical studies were required based on similarities of the proposed device to the predicate device and from the results of the sterilization validation.

#### Conclusion:

Results from the dose mapping study have demonstrated that the alternate sterilization cycle is suitable and does not raise new issues of safety and effectiveness for the finished devices. Based on the indications for use, fundamental scientific technology and a comparison to the predicate devices, the subject Codman Disposable Perforators are substantially equivalent to the predicate devices.