(28 days)
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Not Found
No
The summary describes a simple pacing lead adaptor/extension and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as an adaptor for connecting pacing leads to a pacemaker, which facilitates the function of a therapeutic device (pacemaker) but is not itself a therapeutic device.
No
The "Intended Use" states that the device is for "connecting the pacing lead(s) to a compatible pacemaker header cavity," which describes a functional connection for treatment (pacing), not for diagnosing a condition.
No
The device is described as "Pacing Lead Adaptors/Extensions, unipolar/bipolar," which are physical components used to connect pacing leads to a pacemaker. This description clearly indicates a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect pacing leads to a pacemaker. This is a direct connection to a medical device implanted within the body for therapeutic purposes (pacing the heart).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on in vitro analysis.
- Using reagents or other substances to perform tests outside the body.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and electrical connection for an implanted therapeutic device.
N/A
Intended Use / Indications for Use
Pacing Lead Adaptors/Extensions, unipolar/bipolar are indicated for connecting the pacing lead(s) to a compatible pacemaker header cavity.
Product codes
DTD
Device Description
Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 870.3620 Pacemaker lead adaptor.
(a)
Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2003
Oscor Inc. Ms. Mila Doskocil Director of RA/QA 3816 DeSota Boulevard Palm Harbor, FL 34683
Re: K024156 Trade/Device Name: Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors Regulation Number: 21 CFR 870.3620 Regulation Name: Pacemaker lead adaptor. Regulatory Class: Class II Product Code: DTD Dated: December 16, 2002 Received: December 17, 2002
Dear Ms. Doskocil:
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.
1
Page 2 -- Ms. Mila Doskocil
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) 594-4586. 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 may be obtained 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,
Datum D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment 2
Indications for Use Statement
510k Number (if known) -Device Name: Pacing Lead Adaptors/Extensions, Unipolar/Bipolar
Pacing Lead Adaptors/Extensions, unipolar/bipolar are indicated for connecting the pacing lead(s) to a compatible pacemaker header cavity.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrenceof CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) OR
Over-The-Counter Use ____________
ર્ગ (
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number 1