(87 days)
This device is designed to connect an intravascular electrode to a monitor through a standard EKG patient lead for the purpose of displaying an intravascular signal in real time. Only the black pinjack is "active". The red pinjack is electrically blind and designed to isolate the proximal electrode from inadvertent stimulation.
In essence, the subject device provides an electrically safe connection between the proximal pin of an intravascular electrode and a patient EKG lead , the signal ultimately traveling retrograde along a standard EKG cable to a bedside monitor. It would be used to facilitate placement of a transvenous pacemaker or appropriately designed intravenous catheter with EKG guidance rather than the more cumbersome (and expensive) fluoroscopic approach. The device entirely consists of a pin jack (to accept the proximal pin of the electrode) connected in series via a 1000 ohm resistor to a standard EKG eyelet all encased in an appropriate housing. The snap-fit connection between the EKG lead and device eyelet completes the connection to the monitor.
The provided text does not contain information about acceptance criteria or a study that demonstrates the device meets such criteria. The document is a 510(k) summary for a "Transvenous Pacemaker Placement Assist Device" (formerly "PACER ASSIST DEVICE"), indicating FDA clearance based on substantial equivalence to predicate devices, rather than performance testing against specific acceptance criteria.
The information primarily describes:
- Device Description: An accessory to an EKG cable, consisting of a pin jack, a 1000 ohm resistor, and an EKG eyelet, encased in a housing. Its purpose is to provide an electrically safe connection between an intravascular electrode and a patient EKG lead for displaying an intravascular signal.
- Intended Use: To facilitate placement of a transvenous pacemaker or appropriately designed intravenous catheter with EKG guidance.
- Regulatory Information: Classification as Class II with product codes LDF and DRR, and the FDA's determination of substantial equivalence.
- Key Features: One "active" black pinjack for the signal and one "electrically blind" red pinjack for isolation.
Since no performance study or acceptance criteria are discussed in the provided text, I cannot complete the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or multi-reader studies.
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Copy of file in entirety
sent electronically
KO32613
PETER M. ROTHENBERG, M.D., M.A. 657 CAMINO DE LOS MARES SUITE 137 SAN CLEMENTE, CA 92673 PHONE: (949) 489-9039 FAX: (949) 489-8136 EMAIL: PMRMDINC@SBCGLOBAL.NET
510(k) SUMMARY OF DEVICE
TRADE NAME: PACER ASSIST DEVICE (FORMAL NAME TO BE COPYRIGHTED ON RECEIPT OF 510(K) CLEARANCE)
COMMON NAME: ACCESSORY TO EKG CABLE
CLASSIFICATION NAME: ACCESSORY TO EKG CABLE (CLASSIFICATION TO BE DETERMINED)
CONTACT PERSON: PETER M. ROTHENBERG, M.D., M.A.
As noted in my 510 (k) application, this device is of such simplicity, there are no others directly comparable. Features have been incorporated into those far more technologically advanced. In essence, the subject device provides an electrically safe connection between the proximal pin of an intravascular electrode and a patient EKG lead , the signal ultimately traveling retrograde along a standard EKG cable to a bedside monitor. It would be used to facilitate placement of a transvenous pacemaker or appropriately designed intravenous catheter with EKG guidance rather than the more cumbersome (and expensive) fluoroscopic approach.
The device entirely consists of a pin jack (to accept the proximal pin of the electrode) connected in series via a 1000 ohm resistor to a standard EKG eyelet all encased in an appropriate housing. The snap-fit connection between the EKG lead and device eyelet completes the connection to the monitor.
DATE PREPARED: 10/27/03
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
Peter M. Rothenberg, M.D., M.A. 657 Camino De Los Mares Suite 137 San Clemente, CA 92673
Re: K032613
Trade Name: Transvenous Pacemaker Placement Assist Device Regulation Number: 21 CFR 870.3680 and 870.2050 Regulation Name: Accessory to cardiovascular permanent or temporary pacemaker electrode; and biopotential amplifier and signal conditioner Regulatory Class: Class II (two) Product Code: LDF and DRR Dated: October 30, 2003 Received: November 4, 2003
Dear Dr. Rothenberg:
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.
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Page 2 - Peter M. Rothenberg, M.D., M.A.
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (301) 594-4646. 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 Manufacturers, International 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/dsma/dsmamain.html
Sincerely yours.
Dini Huschur for
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
This device is designed to connect an intravascular electrode to a monitor through a standard EKG patient lead for the purpose of displaying an intravascular signal in real time. Only the black pinjack is "active". The red pinjack is electrically blind and designed to isolate the proximal electrode from inadvertent stimulation.
Dona Seemle
X Prescription device
510(k) Number
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.