(30 days)
Not Found
No
The description focuses on mechanical disengagement based on pressure and does not mention any AI/ML components or algorithms.
No.
The device is described as a tool for perforating the cranium, not for treating a disease or condition. Its function is purely surgical and mechanical.
No
The device's intended use is to "perforate the cranium," which is a surgical action, not a diagnostic one. It is an instrument for performing a procedure, not for identifying the presence or nature of a disease or condition.
No
The device description clearly indicates it is a physical, single-use, sterile device designed to perforate the cranium, made of materials like ABS, and available in different sizes. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Codman Disposable Perforator is a surgical tool designed to physically create a hole in the cranium (skull). It is used directly on the patient's body during a procedure.
- Lack of Diagnostic Testing: The device does not perform any tests on biological samples to diagnose, monitor, or screen for a medical condition. Its function is purely mechanical and procedural.
The description clearly indicates it's a surgical instrument for perforating the cranium, which falls under the category of surgical devices, not IVDs.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HBF
Device Description
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 ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium
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)
Study type: Sterilization Validation
Key results: A full dose mapping study has been performed to ensure there are no new issues relating to the safety or effectiveness of the products. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
(a)
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.(b)
Classification. Class II (performance standards).
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
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 PRAStaff@fda.hhs.gov "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 (301) 443-6740 EF
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Section 5 - 510(k) Summary
| I. Submitter | Integra LifeSciences Corp.
11 Cabot Blvd.
Mansfield, MA 02048 | |
|--------------|---------------------------------------------------------------------|----------------------------------|
| | Establishment Registration Number: 1226348 | |
| | Primary Contact:
Phone: | Jocelyn Raposo
(781) 971-5688 |
| | Secondary Contact:
Phone: | Jennifer Siu
(781) 971-5692 |
Date of Preparation: December 19, 2018
II. Device(s)
| Device Proprietary Name | Codman Disposable Perforators |
|---|---|
| Common Name | Perforators |
| Classification Name | Drills, Burrs, Trephines & Accessories |
| (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 |
| (14mm) | ||
| K071931 | Oct. 22, 2007 | Codman Disposable Perforators |
| (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
Comparison | Codman Disposable
Perforators (Predicates) | Codman Disposable
Perforators (Subject of This
Submission) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for 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. | 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. |
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 | |
| Perforators (Predicates) | Codman Disposable | |
| Perforators (Subject of | ||
| This Submission) | ||
| Manufacturer | Codman & Shurtleff, Inc. | Identical |
| Classification Panel | Neurology | Identical |
| Classification Name | Drills, Burrs, Trephines & | |
| Accessories (Compound, | ||
| Powered) (21 CFR | ||
| 882.4305) | Identical | |
| Indications for 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. | Identical | |
| Operating Principle | With adequate pressure | |
| applied on the perforator | ||
| point, engagement should | ||
| occur as the Hudson End | ||
| is rotated in a driver. Once | ||
| pressure is removed from | ||
| the drill point the device is | ||
| 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 | |
| Perforators (Predicates) | Codman Disposable | |
| Perforators (Subject of | ||
| This Submission) | ||
| Design | 9 mm Perforator | |
| consisting of outer and | ||
| inner body drill, drill | ||
| driver, compression | ||
| spring, drive pin, molded | ||
| sleeve, snap bearing, | ||
| flanged nyliner | ||
| 11mm Perforator | ||
| consisting of outer and | ||
| inner body drill, drill | ||
| driver, compression | ||
| spring, drive pin, molded | ||
| sleeve, snap bearing, | ||
| flanged nyliner | ||
| 14mm Perforator | ||
| consisting of outer and | ||
| inner body drill, drill | ||
| driver, compression | ||
| spring, drive pin, molded | ||
| sleeve, snap bearing, | ||
| flanged nyliner | Identical | |
| Shelf Life | 5 years | Identical |
| Sterilization Method | Gamma | Identical |
| Sterility Assurance Level | ||
| (SAL) | 10-6 | Identical |
| Packaging | PETG Blister Tray with | |
| heat-sealed lid placed into | ||
| 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 / | ||
| Purpose | Acceptance Criteria | Result | |
| Full Dose Mapping | |||
| Validation | Establish a new | ||
| gamma radiation | |||
| sterilization cycle in | |||
| compliance with | |||
| ISO 11137-1 | Dose Uniformity Ratio: |