(28 days)
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No
The summary describes simple electrical adapters for connecting leads and does not mention any computational or analytical functions, let alone AI/ML.
No
The device descriptions indicate that these models are adapters designed to connect different types of leads and terminals, which are components used in medical devices but are not therapeutic devices themselves. They facilitate the function of other devices rather than providing therapy.
No
The devices (Model 6017, 6018, 6020) are described as adapters for joining medical leads with different connectors. Their intended use is to connect existing leads, not to provide diagnostic information about a patient's condition.
No
The intended use describes physical adapters for connecting leads and terminals, indicating a hardware device. There is no mention of software functionality.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly describes the devices as adapters designed to connect different types of leads and terminals for medical devices (likely pacemakers or similar implantable devices). This is a function related to the physical connection of components within a medical system, not the analysis of biological samples in vitro.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
- Measuring biomarkers
These devices are accessories or components used to facilitate the proper functioning of other medical devices, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
- Model 6017: It is designed to join CPI bipolar leads having 3.2mm inline connectors to 5mm (4.75) bifurcated bipolar terminals.
- Model 6018: It is a single barrel adapter that is designed to join CPI unipolar leads having a 6mm (5.38) unipolar connector to 3.2mm low profile unipolar terminal.
- Model 6020: It is a single barrel adapter that is designed to join CPI unipolar leads having a 5mm (4.75) unipolar connector to 3.2mm low profile unipolar terminal.
Product codes
DTD
Device Description
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2004
Guidant Corporation c/o Ms. Amita Shenai Regulatory Affairs Associate Cardiac Rhythm Management 4100 Hamline Avenue North St. Paul. MN 55112
Re: K041574
Trade Name: Pacemaker Lead Adapter Regulation Number: 21 CFR 870.3620 Regulation Name: Pacemaker Lead Adaptor Regulatory Class: II (two) Product Code: DTD Dated: June 11, 2004 Received: June 14, 2004
Dear Ms. Shenai:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered proct of they 20, 1978, is accordance with the provisions of the Federal Food, DNI, devices that have boon require approval of a premarket approval application (PMA). and Cosmetic Act (710) that the novice, subject to the general controls provisions of the Act. The r ou may, merelore, mans. of the Act include requirements for annual registration, listing of general connois profilesing 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Couvecements concerning your device in the Federal Register.
1
Page 2 - Ms. Amita Shenai
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) 594-4648. 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,
Neil R.P. Ogden
Bram D. Zuckerman, M.I Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K041574
Device Name: Models 6017, 6018, and 6020
Indications For Use:
- Model 6017:
It is designed to join CPI bipolar leads having 3.2mm inline connectors to 5mm (4.75) bifurcated bipolar terminals.
-
Model 6018: It is a single barrel adapter that is designed to join CPI unipolar leads having a 6mm (5.38) unipolar connector to 3.2mm low profile unipolar terminal.
-
Model 6020: It is a single barrel adapter that is designed to join CPI unipolar leads having a 5mm (4.75) unipolar connector to 3.2mm low profile unipolar terminal.
Michard Ogden for 602
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Nu
| Prescription Use | X |
|---|---|
| Counter Use | |
| (Part 21 CFR 801 Subpart D) | |
| Subpart C) |
AND/OR
Over-The-
(21 CFR 807(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)