(34 days)
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No
The summary describes a permanent pacing lead, a physical medical device, and does not mention any software or algorithms that would incorporate AI or ML.
Yes
The device is a permanent pacing lead used for pacing and sensing the heart, which is a therapeutic function aimed at treating cardiac conditions.
No
Explanation: The device is a permanent pacing lead used for pacing and sensing the heart, which is a therapeutic function rather than a diagnostic one. It works in conjunction with a pacemaker to regulate heart rhythm.
No
The device description clearly states "Permanent Pacing Lead, Model Refino", which is a physical hardware component (a lead) used in conjunction with a pacemaker. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pacing and sensing of the ventricle and / or atrium of the heart" and is used "in conjunction with a compatible implantable pulse generator (pacemaker)". This describes a device that is implanted within the body to directly interact with the heart's electrical activity.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are performed outside of the body.
This device is clearly an implantable medical device used for therapeutic and diagnostic purposes within the body, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Permanent pacing lead, Model Refino ™ is indicated for pacing and sensing of the ventricle and / or atrium of the heart. The lead is used in conjunction with a compatible 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 and / or atrium of the heart
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
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 7 2004
Oscor, Inc. c/o Ms. Mila Doskocil Director of Regulatory Affairs/Compliance 3816 DeSoto Boulevard Palm Harbor, FL 34683
Re: K040569
Trade Name: Permanent Pacing Lead, Model Refino Regulation Number: 21 CFR 870.3680 Regulation Name: Permanent Pacemaker Electrode Regulatory Class: III (three) Product Code: DTB Dated: March 03, 2004 Received: March 04, 2004
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.
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Page 2 - Ms. Mila Doskocil
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,
Dina R. Lo Jones
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number :K040569
Device Name: Permanent Pacing Lead, Model Refino ™
Permanent pacing lead, Model Refino ™ is indicated for pacing and sensing of the ventricle and / or atrium of the heart. The lead is used in conjunction with a compatible implantable pulse generator (pacemaker).
Prescription Use_ ✓ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (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)
ina P. Lechner
(Division Sign-Off)
Division of C
ervices
JIVAKi ing
K040569