(107 days)
Not Found
No
The device description and intended use clearly define the device as cables and adapters for connecting pacing leads to a Pacing System Analyzer. There is no mention of any computational or analytical functions that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a cable or adapter intended to connect leads to a Pacing System Analyzer (PSA), which is a testing device, not a therapeutic device.
No
The device description indicates that the cables/adapters are intended to connect leads to a testing device like a Pacing System Analyzer (PSA), which performs diagnostic functions. However, the cables/adapters themselves are simply connectors and do not perform the diagnostic analysis. They facilitate the connection to a diagnostic device, but are not diagnostic devices themselves.
No
The device description and intended use clearly describe physical cables and adapters used to connect medical devices. There is no mention of software as the primary or sole component.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these cables and adapters are used to connect cardiac pacing leads to Pacing System Analyzers (PSAs). PSAs are used to test the function of pacing systems, which are implanted medical devices. This is a functional test of a medical device, not a diagnostic test performed on a biological sample (like blood, urine, or tissue) to determine the presence or state of a disease or condition.
- Device Description: The devices are described as cables and adapters, which are accessories used in conjunction with other medical devices (pacing leads and PSAs).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of analytes (substances in biological samples).
- Diagnosis, monitoring, or screening of diseases or conditions based on biological sample analysis.
These devices are accessories used in the functional testing of cardiac pacing systems, which falls under the category of medical device accessories, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Model 4160 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.
The Model 4161 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing device such as a PSA (Pacing System Analyzer) located outside the sterile field.
The Model 4053A non-disposable PSA cable adapter is intended to be used with the St. Jude Medical Model 4051 and 4051A cables to connect a cardiac pacing lead to the SJM Model 3150 PSA or Biotronik model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.
Product codes (comma separated list FDA assigned to the subject device)
DSA, DTA
Device Description
PSA Cable Model Numbers 4160 and 4161; PSA Cable Adapter Model Number 4053A. Disposable Surgical PSA cables; Non-Disposable PSA adapters.
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): 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.
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.
Not Found
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).
Not Found
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).
0
PREMARKET NOTIFICATION [510(K)] SUMMARY
Date Prepared:
March 30, 2010
Sylmar, CA 91342
St. Jude Medical, CRMD 15900 Valley View Court APR - 2 2010
Submitter: Address:
Phone: Fax:
Contact Person:
Beena Flynn
818-493-3592
818 493-3615
Trade Name/Proprietary Name:
PSA Cable Model Numbers 4160 and 4161 PSA Cable Adapter Model Number 4053A
Disposable Surgical PSA cables Non-Disposable PSA adapters
Class II, 21 CFR 870.3720
Class II, 21 CFR 870.2900
Classification:
Common Name:
Legally marketed device to which your firm is claiming equivalence:
St. Jude Medical PSA cables and adapters under review are all currently commercially available.
| Model
Number
(Cables) | Equivalent
Device | PMA Number | Approval Date |
|-----------------------------|----------------------|----------------------------------------------------|------------------|
| 4160 | 4160 | P910023 / S154,
P030054 / S67,
P950022 / S42 | January 13, 2009 |
| 4161 | 4161 | P910023 / S154,
P030054 / S67,
P950022 / S42 | January 13, 2009 |
| Model Number
| (Adaptor) | Equivalent Device | 510(k) Number | Approval Date |
|---|---|---|---|
| 4053A | Remington | ||
| Medical | |||
| cable | |||
| adapter | |||
| Model 4053 | K971968 | July 23, 1997 |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a logo for the Department of Health & Human Services-GSA. The logo consists of a circular arrangement of text surrounding a stylized image of a bird in flight. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-GSA" in a circular pattern. The bird is depicted with flowing lines, suggesting movement and freedom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
St. Jude Medical CRMD c/o Ms. Beena Flynn Regulatory Affairs 15900 Valley View Court Sylmar, CA 91342
APR - 2 2010
Re: K093858
Trade/Device Name: PSA Cable Model Numbers 4160 and 4161 PSA Cable Adapter Model Number 4053A Regulation Number: 21 CFR 870.2900 Regulation Name: Patient transducer and electrode cable (including connector) Regulatory Class: Class II (two) Product Code: DSA and DTA Dated: December 15, 2009 Received: December 16, 2009
Dear: Ms. Flynn
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 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.
2
Page 2 - Ms. Beena Flynn
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115800.html from the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE
Device Name: PSA Cable Model Numbers 4160 and 4161
Indications for Use: The Model 4160 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.
The Model 4161 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing device such as a PSA (Pacing System Analyzer) located outside the sterile field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(Division Sign-Off)
Division of Cardiovascular Devi
| 510(k) Number | K693858 |
|---|---|
| --------------- | --------- |
Page 2
4
STATEMENT OF INDICATIONS FOR USE
Device Name: PSA Cable Adapter Model Number 4053A
Indications for Use: The Model 4053A non-disposable PSA cable adapter is intended to be used with the St. Jude Medical Model 4051 and 4051A cables to connect a cardiac pacing lead to the SJM Model 3150 PSA or Biotronik model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
. .
Over-The-Counter Use (21 CFR 801 Subpart C)
Carlos Concession Company Control Concession Company Controller Collection Come Concession Comercial Concession