(192 days)
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No
The summary describes a passive cardiac lead, a purely hardware component, and makes no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is a permanent lead indicated for ventricular placement and is used in conjunction with an implantable pulse generator, which implies it's used to treat a medical condition by assisting or regulating heart function.
No
Explanation: The provided text describes a "tined passive tip permanent lead" which is indicated for "ventricular placement" and used in conjunction with an "implantable pulse generator." This describes a component of an implantable medical device, likely a pacemaker or defibrillator lead, which is therapeutic in nature (delivering electrical pulses), not diagnostic. There is no mention of the device being used to identify or analyze a disease or condition.
No
The device description clearly indicates a "tined passive tip permanent lead," which is a physical hardware component intended for implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "tined passive tip permanent lead indicated for ventricular placement." This describes a device that is implanted within the body to interact with the heart's electrical system.
- Anatomical Site: The anatomical site is "ventricular," referring to a part of 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 based on in vitro analysis.
- Using reagents or assays.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is an implantable medical device used for pacing the heart.
N/A
Intended Use / Indications for Use
The tined passive tip permanent lead is indicated for ventricular placement. The lead is used in conjunction with an implantable pulse generator. A variety of pulse generators can be used in combination with the lead. The lead will connect directly to many commercially available pulse generators. Some pulse generators require the use of a commercially available adapter to make the connection to the lead.
Product codes
DTB
Device Description
Sulzer Oscor Permanent, Passive Tined Pacing Lead, Model HT-PB
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
ventricular
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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§ 870.3680 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a symbol consisting of three stylized human profiles facing to the right, with a hand-like shape above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Ms. Mila Doskocil Manager, Quality Assurance and Regulatory Affairs Sulzer Oscor, Inc. 3816 DeSoto Boulevard Palm Harbor, FL 34683
K990142 Re: Model HT PB Pacing Leads & Model SS Positioning Stylet Accessory Requlatory Class: III (three) Product Code: DTB April 28, 1999 Dated: May 3, 1999 Received:
Dear Ms. Doskocil:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, and 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 Existing major requlations affecting your device can be additional controls. found in the Code of Federal Requlations, 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
1
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 vour device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- __. Additionally, for questions on the promotion or advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 at (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Christopher.A.Horton
Thomas J.Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)- K990142
Device Name:
Sulzer Oscor Permanent, Passive Tined Pacing Lead, Model HT-PB
Indications for Use:
The tined passive tip permanent lead is indicated for ventricular placement. The lead is used in conjunction with an implantable pulse generator. A variety of pulse generators can be used in combination with the lead. The lead will connect directly to many commercially available pulse generators. Some pulse generators require the use of a commercially available adapter to make the connection to the lead.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
OR
Over-The-Counter Use
Myrtle for Callahan
Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number