(261 days)
Not Found
Not Found
No
The summary describes a physical pacing wire and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for temporary atrial and ventricular pacing, which is a therapeutic intervention for cardiac function.
Yes
The device is indicated for "temporary atrial and ventricular pacing and sensing," and the term "sensing" implies diagnostic capabilities.
No
The device description explicitly states it is composed of metallic wire, insulation coating, and needles, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary atrial and ventricular pacing and sensing during and after cardiac surgery." This describes a device used in vivo (within the body) for therapeutic and diagnostic purposes related to the heart's electrical activity.
- Device Description: The description details a physical wire with needles and insulation designed for insertion into the body. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose or monitor conditions. This device is designed to interact directly with the heart within the body.
N/A
Intended Use / Indications for Use
- Intended Use: The RIVER Medical Temporary Cardiac Pacing Wire is a nonabsorbable surqical cardiac pacer lead with dual needle intended to be used for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is SINGLE USE ONLY. The device is supplied nonsterile on OEM basis only.
- Indications: The RIVER Medical Disposable Temporary Cardiac Pacing Wire is indicated for use in temporary atrial and ventricular pacing and sensing during and after cardiac surgery.
Product codes
LDF
Device Description
The proposed device and the predicate device(s) are composed of metallic 28- to 32-gauge wire, an extruded insulation coating, a special curved needle to ease the transcutaneous placement of the electrode in the skin, and a snap-off straight needle. The leads are available in various sizes, lengths, and quantities. The predicate and proposed devices are manufactured in compliance with special controls/performance standards as dictated by 21 CFR 898; 62 FR 25497 26 USP Sutures - Needle Attachment, Tensile Strength - Surgical sutures, Sterility Tests, Sutures - Diameter. ANSI/AAMI/ISO 10993-7. IEC 60601-1-Sub-Clause 6.1; IEC 601-1; Sub-Clause 4.10; IEC 601-1, Sub-Clause 44.7; IEC 60601-1, Sub-Clause 20.4, IEC 60601-2-27, Clause 20.3 ANSI/AAMI EC 53, Cl. 5.5.1; IEC 60601-1, Sub-Clause 19.4h, ANSI/AAMI EC53, Clause 5.5.2; IEC 60601-1, Cl. 21.5, IEC 60601-2-27, Cl. 21.5, UL 2601; 55; ANSI/AAMI EC53, Clause 5.5.10; IEC 60601-1, Sub-Clause 57.4a, ANSI/AAMI EC 53, Clause 5.5.6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
JUN 1 1 2003
Summary of Safety and Effectiveness
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the proposed RIVER Medical RIVER-WIRE component device.
| Manufacturer: | RIVER Medical, Inc.
836 NE 24th Avenue
Portland, OR 97232
PHONE: (503) 230-1280
FAX: (503) 233-1152 |
|-------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Ann Greenawalt, Vice President
Legal & Regulatory Affairs |
| Device Name: | |
| Trade Name: | Disposable Temporary Pacing Wire |
| Common Name: | Component to diagnostic or physiological
monitoring devices |
| Proprietary name: | RIVER Wire™ |
| Classification: | Cable, Transducer and Electrode, Patient (including
Connector), Cardiovascular, LDF, Class II |
| Date Prepared: | September 19, 2002 |
Device Description: The proposed device and the predicate device(s) are composed of metallic 28- to 32-gauge wire, an extruded insulation coating, a special curved needle to ease the transcutaneous placement of the electrode in the skin, and a snap-off straight needle. The leads are available in various sizes, lengths, and quantities. The predicate and proposed devices are manufactured in compliance with special controls/performance standards as dictated by 21 CFR 898; 62 FR 25497 26 USP Sutures - Needle Attachment, Tensile Strength - Surgical sutures, Sterility Tests, Sutures - Diameter. ANSI/AAMI/ISO 10993-7. IEC 60601-1-Sub-Clause 6.1; IEC 601-1; Sub-Clause 4.10; IEC 601-1, Sub-Clause 44.7; IEC 60601-1, Sub-Clause 20.4, IEC 60601-2-27, Clause 20.3 ANSI/AAMI EC 53, Cl. 5.5.1; IEC 60601-1, Sub-Clause 19.4h, ANSI/AAMI EC53, Clause 5.5.2; IEC 60601-1. Cl. 21.5, IEC 60601-2-27, Cl. 21.5, UL 2601; 55; ANSI/AAMI EC53, Clause 5.5.10; IEC 60601-1, Sub-Clause 57.4a, ANSI/AAMI EC 53, Clause 5.5.6.
1
- Intended Use: The RIVER Medical Temporary Cardiac Pacing Wire is a nonabsorbable surqical cardiac pacer lead with dual needle intended to be used for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is SINGLE USE ONLY. The device is supplied nonsterile on OEM basis only.
Indications: The RIVER Medical Disposable Temporary Cardiac Pacing Wire is indicated for use in temporary atrial and ventricular pacing and sensing during and after cardiac surgery.
Comparison of Technological Characteristics: The proposed device, the disposable temporary pacing wire, comprises the same or similar material as the predicate device. Manufacture of this device, and QC testing, is in substantial compliance with current 21 CFR 898; 62 FR 2549726 USP Sutures - Needle Attachment, Tensile Strength - Surgical sutures. Sterility Tests. Sutures - Diameter. ANSI/AAMI/ISO 10993-7. IEC 60601-1-Sub-Clause 6.1; IEC 601-1, Sub-Clause 4.10; IEC 601-1, Sub-Clause 44.7; IEC 60601-1, Sub-Clause 20.4, IEC 60601-2-27, Clause 20.3 ANSI/AAMI EC 53, Cl. 5.5.1; IEC 60601-1, Sub-Clause 19.4h, ANSI/AAMI EC53, Clause 5.5.2; IEC 60601-1, Cl. 21.5, IEC 60601-2-27, Cl. 21.5, UL 2601; 55; ANSI/AAMI EC53, Clause 5.5.10; IEC 60601-1, Sub-Clause 57.4a, ANSI/AAMI EC 53, Clause 5.5.6.
end
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2003
RIVER Medical, Inc. c/o Ms. Mary Ann Greenawalt Vice President Legal & Regulatory Affairs 836 NE 24th Avenue Portland, OR 97232
Re: K023174
Trade Name: Disposable Temporary Pacing Wire Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular permanent or temporary pacemaker electrode. Regulatory Class: Class II (two) Product Code: LDF Dated: April 28, 2003 Received: May 5, 2003
Dear Ms. Greenawalt:
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
3
Page 2 - Ms. Mary Ann Greenawalt
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) 594-4646. 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,
NoQalettun
Bram 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
4
Page __ 1 __ of____ 1 __
INDICATIONS FOR USE
510(k) (if known):
DEVICE Name:
Disposable Temporary Pacing Wire
Indications for Use:
The RIVER Medical Disposable Temporary Cardiac Pacing Wire is indicated for use in temporary atrial and ventricular pacing and sensing during and after cardiac surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ 510(k) Num
Concurrence of CDRH, Office of Device Evaluation (ODE)