DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260

K012392 · Pace Medical · DSA · Sep 4, 2001 · Cardiovascular

Device Facts

• Record ID: K012392
• Device Name: DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
• Applicant: Pace Medical
• Product Code: DSA · Cardiovascular
• Decision Date: Sep 4, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Intended Use

For use in conjunction with a Model 4815 Adapter for connecting a non-sterile pacing (system) analyzer to a patient's cardiac pacing lead system, allowing the analyzer to be located at some distance from the patient, outside of the sterile field.

Device Story

Disposable extension cables (Models 4255, 4260) facilitate electrical connection between cardiac pacing lead systems and non-sterile pacing analyzers; used in clinical settings to maintain sterile field integrity by allowing analyzer placement at a distance from the patient; operated by clinicians; provides physical electrical pathway; benefits patient by enabling necessary diagnostic/pacing analysis without compromising sterile environment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable extension cables; electrical connectivity; non-sterile; designed for use with Model 4815 Adapter.

Indications for Use

Indicated for patients requiring connection of a cardiac pacing lead system to a non-sterile pacing analyzer, enabling the analyzer to be positioned outside the sterile field during clinical procedures.

Regulatory Classification

Identification

A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 4 2001

Mr. Robert C. Mace Manager Quality Assurance and Regulatory PACE Medical, Inc. 391 Totten Pond Road Waltham, MA 02451

K012392 Re:

Model 4255 or Model 4260 Disposable Extension Cables Regulation Number: 870.3600 Regulatory Class: II (two) Product Code: 74 DSA Dated: July 25, 2001 Received: July 27, 2001

Dear Mr. Mace:

We have reviewed your Section 510(k) notification of intent to market the device referenced w onewed your betermined the device is substantially equivalent (for the indications for use above and we nave acteriment of the marketed predicate devices marketed in interstate commerce surved in the energians, to regarment 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). You may, therefore, market the device, subject to the general controls Cosmotic Pro (110). I The general controls provisions of the Act include requirements for annual provibions of itis Prod - Prod - Process, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Freniance in provide can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to maportion the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Robert C. Mace

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nodicate 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 and n you deelie specific and vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (2017) 591 10. 1 runners at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionination on your respeal and Consumer Assistance (DSMICA) at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: Model 4255 or Model 4260 Disposable Extension Cables

## INDICATIONS FOR USE

"For use in conjunction with a Model 4815 Adapter for connecting a non-sterile pacing (system) analyzer to a patient's cardiac pacing lead system, allowing the analyzer to be located at some distance from the patient, outside of the sterile field."

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use / (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2)

Dakitah

Division of Cardiovascular & Respiratory Devices
510(k) Number K012392