(41 days)
Not Found
Not Found
No
The summary describes a simple tubing and cord set for irrigation and energy delivery, with no mention of AI or ML capabilities. The performance studies focus on basic electrical and fluid delivery standards.
No
The device provides irrigation and energy to bipolar forceps, which are used for "electrosurgery," implying a surgical or diagnostic function rather than a direct therapeutic one by the device itself.
No
The device is described as providing irrigation and energy to bipolar forceps for electrosurgery, which are therapeutic functions, not diagnostic.
No
The device description clearly states it is a "Tubing and Bipolar Cord Set," which are physical hardware components used for irrigation and energy delivery. It also mentions a "co-extrusion process" to integrate these physical parts.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes providing irrigation and energy to bipolar forceps for surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (testing samples outside the body).
- Device Description: The description focuses on the physical components and their function in delivering irrigation and energy during surgery. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
The device is clearly intended for use in a surgical setting to facilitate electrosurgery, which is a therapeutic procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Codman Integrated Irrigation Tubing and Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
They are intended for use with the Codman/Malis CMC®-II and the Codman/Malis CMC® III I.E.C. Irrigation Modules and the Codman/Malis Bipolar Coagulators.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Codman Integrated Irrigation Tubing and Bipolar Cord Set is designed to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation. A co-extrusion process integrates a disposable bipolar cord into the irrigation tubing. This integrated set allows for one unit instead of two units and helps to keep the bipolar electrosurgery organized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Substantial equivalence for this device is based upon comparison to predicate device performance testing. Device qualification criteria meet all device characteristics and qualification criteria for the predicate device. Tests meet or exceed the minimum levels set forth by the Association for the Advancement of Medical Instrumentation in the ANSI/AAMI HF18: 2001: Electrosurgical devices § 4.2.5.1-3, 5.
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.
The document states "similar in intended use, materials, design, and principles of operation" to the Codman/Malis Integrated Irrigation Tubing and Bipolar Cord Set, but does not provide a K/DEN number for the predicate device.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
OCT 17 2005
Page 1 of 2
510(k) Summary Codman Integrated Irrigation Tubing and Bipolar Cord
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person
Joan Q. Bartle, RAC Sr. Regulatory Affairs Specialist Telephone Number: (508) 828-2840 Fax Number: (508) 828-2777
Name of Device
| Proprietary Name: | Codman Integrated Irrigation Tubing and Bipolar Cord Set |
|---|---|
| Common Name: | Irrigation Tubing and Bipolar Cord |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
Device Classification
Electrosurgical Cutting and Coagulation Device and Accessories are Class II devices per 21 CFR § 878.4400 (79 GEI).
Statement of Substantial Equivalence
Codman Integrated Irrigation Tubing and Bipolar Cord Sets are substantially equivalent to the Codman/Malis Integrated Irrigation Tubing and Bipolar Cord Set based on the device's similarity to the predicate device in intended use, materials, design, and principles of operation.
Indications for Use
The Codman Integrated Irrigation Tubing and Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
They are intended to for use with the Codman/Malis CMC®-II and the Codman/Malis CMC® III 1.E.C. Irrigation Modules and the Codman/Malis Bipolar Coagulators.
1
052449
Page 2 of (2)
Physical Description
The Codman Integrated Irrigation Tubing and Bipolar Cord Set is designed to rnc Outfiel irrigation and energy simultaneously to bipolar forceps specifically provide infigation and onergy extrusion process integrates a disposable bipolar designed for infigation. A oo extraction pregrated set allows for one unit instead of two units and helps to keep the bipolar electrosurgery organized.
Device Testing
Substantial equivalence for this device is based upon comparison to predicate Oubstantial oquivalismo vor «rformance testing. Device qualification criteria meet ac nee characterialio and alification criteria for the predicate device. Tests meet or exceed the minimum has forth by the Association for the Advancement of the performance online of tons.in in the ANSI/AAMI HF18: 2001: Electrosurgical devices § 4.2.5.1-3, 5.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a modern, abstract design.
9200 Corp
Rockville
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Codman & Shurtleff, Inc. c/o Patricia L. Murphy Third Party Officials Reviewer KEMA Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914
Re: K052449
Trade/Device Name: Codman Integrated Irrigation Tubing and Bipolar Cord Set Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 7, 2005 Received: October 11, 2005
OCT ] 7 2005
Dear Ms. Murphy:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); 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.
3
Page 2- Patricia L. Murphy
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter natification. The FDA finding of substantial equivalence of your device to a legally premailer noticate device results in a classification 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 11 you doon office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Zack N. McAllister
- Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Codman Integrated Irrigation Tubing and Bipolar Cord Set
Indications For Use:
The Codman Integrated Irrigation Tubing and Bipolar Cord Sets are intended to The Codman integrated inigation Tobing Sha Expolar forceps specifically designed for irrigation.
They are intended for use with the Codman/Malis CMC®-II and the They are intended for use with the Oodmaninations
Codman/Malis CMC® III I.E.C. Irrigation Modules and the Codman/Malis Bipolar Coagulators.
Prescription Use
(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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052449