(31 days)
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Not Found
No
The summary describes a permanent pacing lead, a traditional medical device, and makes no mention of AI, ML, image processing, or any related concepts.
Yes
The device is a permanent pacing lead used for pacing and sensing the ventricle, which falls under the definition of a therapeutic device designed to treat a medical condition.
No
This device, a permanent pacing lead, is described as being indicated for "pacing and sensing of the ventricle" and is used with a pacemaker. Its function is to provide electrical impulses for heart rhythm, not to diagnose a condition.
No
The device is described as a "Permanent pacing lead, Model PY2," which is a physical implantable medical device used for pacing and sensing. It is explicitly stated to be used "in conjunction with a compatible, market cleared, implantable pulse generator (pacemaker)," which is also a hardware device. There is no mention of software being the primary or sole component of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Permanent pacing lead, Model PY2, is indicated for pacing and sensing of the ventricle." This describes a device that is implanted in the body to interact directly with the heart's electrical activity.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory testing, or diagnostic purposes based on bodily fluids or tissues.
Therefore, the device described is a medical device used for therapeutic and sensing purposes within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Permanent pacing lead, Model PY2, is indicated for pacing and sensing of the ventricle and is used in conjunction with a compatible, market cleared, implantable pulse generator (pacemaker).
Product codes
DTB
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
ventricle
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.
Not Found
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings forming three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2004
Oscor, Inc. c/o Ms. Mila Doskocil Director of Regulatory Affairs/Compliance 3816 DeSoto Boulevard Palm Harbor, FL 34683
Re: K041809
18641609
Trade Name: Permanent Pacing Lead, Model PY2 Regulation Number: 21 CFR 870.3680 Regulation Number. 21 CFR 070.5000
Regulation Name: Cardiovascular Permanent or Temporary Pacemaker Electrode Regulatory Class: III (three) Product Code: DTB Dated: July 2, 2004 Received: July 6, 2004
Dear Ms. Doskocil:
We have reviewed your Section 510(k) premarket notification of intent to market the device the indication we have reviewed your Section 910(tr) premained in substantially equivalent (for the indications referenced above and nave ucterimmed the actived predicate devices marketed in interstate for use stated in the enclosure) to tegary marketed proxical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been recalssined in accessful of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the and Cosment Act (Act) that do not require appro (the general controls provisions of the Act. The You may, therefore, market the dovices, soloject of the ments for annual registration, listing of
general controls provisions of the Act include requirements for and general controls provisions of the rict mercials required adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (SCC above) this efficial case of considerating your device can
may be subject to such additional controls. Existing major regulation FDA may may be subject to such additional controls. Extrems, major of 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In additio be found in the Code of Peachariting your device in the Federal Register.
1
Page 2 – Ms. Mila Doskocil
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a succession in ther requirements of the Act
that FDA has made a determination that your device complies with other must that FDA nas made a decidination that your do roos by other Federal agencies. You must listing and listin or any Federal statutes and regulations daminibers or registration and listing (21) comply with all the Act s requirements, me; good manufacturing practice requirements as setting the closes CFK Part 807); labeling (21 CFR Part 820); go de if applicable, the electronic forth in the quanty systems (QD) regalations 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Deciolis 591 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -I his letter will anow you to begin manothy of substantial equivalence of your device to a legally premarket nothcation. The PDA miding of sactualian of a
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 If you desire specific advice for your ac now and one and the regulation entitled, comacr the Office of Complanse at (5 x 7, xification" (21CFR Part 807.97). You may obtain " Misorallumig by reference to premanter robilities. Section the Act from the Division of Small other general information on your responsive in the eat 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. Ogden
Bram D. Zuckermañ, M. 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): K041809
Device Name: Permanent Pacing Lead, Model PY2
Indications For Use:
Indications For Use.
Permanent pacing lead, Model PY2, is indicated for pacing and sensing of the ventricle r cirianent pading four, mouth is used in conjunction with a compatible, market cleared, implantable pulse generator (pacemaker).
Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K041809 |
|---|---|
| --------------- | --------- |
BDZ