(182 days)
Not Found
No
The device is a simple electrical extension cable and the description and performance studies focus on electrical and physical integrity, with no mention of AI or ML.
No.
The device is an electrical extension cable designed to connect a pacing system analyzer or temporary pacemaker to a cardiac lead; it does not directly provide therapy but facilitates the connection for therapeutic devices.
No
Explanation: The device is described as an "electrical extension cable" used to connect a pacing system analyzer or temporary pacemaker to a cardiac lead. Its function is to transmit signals or power, not to diagnose a condition itself. It facilitates the use of other devices that might be diagnostic (like a PSA), but it is not diagnostic on its own.
No
The device description clearly states it is an "electrical extension cable" with physical components like alligator clips and a safety plug, designed to transmit electrical signals. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect a pacing system analyzer or temporary pacemaker to a cardiac lead. This is a direct connection to a patient's electrical system for pacing or analysis, not for testing samples (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description details an electrical extension cable for transmitting signals or power to patient-connected electrodes. This is a medical device used in vivo (within the body or directly connected to the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic testing.
Therefore, the PXT701 Disposable Temporary Pacing Cable is a medical device used for cardiac pacing and analysis, not an IVD.
N/A
Intended Use / Indications for Use
The PXT701 Disposable Temporary Pacing Cable is designed to connect a pacing system analyzer (PSA) or temporary pacemaker to a cardiac lead.
Product codes
DSA
Device Description
The Disposable Temporary Pacing Cable is an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes. The cable is bipolar, with alligator clips at the end of the cable that will be attached to the patient leads, and a safety plug instrument connector at the other end that allows electrical connection to a pacing system analyzer or to an external pacing system (temporary pacemaker). The alligator clips are color coded (red = positive; black = negative). The cable is approximately 2.5 meters (8 feet) long, and is supplied sterile. The cable is a disposable, single-patient use device.
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
Performance testing for the Tiger Medical Products Disposable Temporary Pacing Cable consists of physical integrity and electrical resistance in accordance with ANSI/AAMI EC53:2013 (dielectric withstand voltage, defibrillation withstand test, cable and leadwire noise, sink current, connector tensile strength, connector flex life testing, number of connector mate/unmate cycles, contact resistance, connector retention force and patient leadwire resistance). The Tiger Medical Products Disposable Temporary Pacing Cable has met all applicable acceptance criteria as defined in ANSVAAMI EC53:2013 with the exception of cable noise. The test results for cable noise were equivalent to the results of the same testing performed on the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a depiction of a caduceus, which is a traditional symbol of medicine, with a modern and abstract design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 05, 2016
Tiger Medical Products % Pamela Papineau President Delphi Medical Device Consulting, Inc 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K152947
Trade/Device Name: Disposable Temporary Pacing Cable Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: February 16, 2016 Received: February 19, 2016
Dear Pamela Papineau:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 vours.
M.A. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K152947
Device Name
Disposable Temporary Pacing Cable
Indications for Use (Describe)
The PXT701 Disposable Temporary Pacing Cable is designed to connect a pacing system analyzer (PSA) or temporary pacemaker to a cardiac lead.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary (K152947) - Page 1 of 3
General Information
| Owner's Name: | Tiger Medical Products |
|---|---|
| Address: | Jaje Plaza, Suite 703 |
| 1717 North Sichuan Road | |
| Shanghai, China 200080 | |
| Telephone: | 404-696-6999 |
| Contact Person: | Pamela Papineau, RAC (US, EU, CAN) |
| Delphi Medical Device Consulting, Inc. | |
| 5 Whitcomb Avenue | |
| Ayer, MA 01432 | |
| Telephone Number: | (978) 772-3552 |
| Fax Number: | (978) 796-5460 |
| Subject Device: | |
| Trade Name: | Disposable Temporary Pacing Cable |
| Common Name: | Component to diagnostic or physiological monitoring devices |
| Product Code: | DSA |
| FDA Regulation: | 21 CFR 870.2900 – Cable, Transducer and Electrode, Patient |
| (Including Connector) | |
| Device Classification: | Class II |
| Predicate Device: | |
| Product Name: | Safe Connect Disposable Surgical Cable |
| Common Name: | Component to diagnostic or physiological monitoring devices |
| Product Code: | DSA |
| FDA Regulation: | 21 CFR 870.2900 – Cable, Transducer and Electrode, Patient |
| (Including Connector) | |
| Device Classification: | Class II |
| Premarket Notification: | K971968 |
Indications for Use
The PXT701 Disposable Pacing Cable is designed to connect a pacing system analyzer (PSA) or temporary pacemaker to a cardiac pacing lead.
Device Description:
The Disposable Temporary Pacing Cable is an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes. The cable is bipolar, with alligator clips at the end of the cable that will be attached to the patient leads, and a safety plug instrument connector at the other end that allows electrical connection to a pacing system analyzer or to an external pacing system (temporary pacemaker). The alligator clips are color coded (red = positive; black = negative). The cable is approximately 2.5 meters (8 feet) long, and is supplied sterile. The cable is a disposable, single-patient use device.
4
510(k) Summary (K152947) – Page 2 of 3
Substantial Equivalence
The Tiger Medical Products Disposable Temporary Pacing Cable is substantially equivalent to the Remington Medical, Inc. Safe Connect Surgical Cable (K971968). Substantial equivalence, which is summarized below, is based on indications for use and device physical and technological characteristics.
| Tiger Medical Products | Remington Medical, Inc. | |
|---|---|---|
| Disposable Temporary Pacing | Disposable Surgical Cable | |
| Cable (current submission) | (K971968) | |
| Device Common/Usual | Component to diagnostic or | |
| physiological monitoring devices | Component to diagnostic or | |
| physiological monitoring devices | ||
| Name | ||
| Device Class | Class II | Class II |
| Product Code / Regulation | DSA / 21 CFR 870.2900 | DSA / 21 CFR 870.2900 |
| Regulation Name | Cable, Transducer and Electrode, | |
| Patient (Including Connector) | Cable, Transducer and Electrode, | |
| Patient (Including Connector) | ||
| Prescription Use | Rx Only | Rx Only |
| Intended Use | For temporary connection of a | |
| pacing system analyser (PSA) or | ||
| temporary pace maker to a cardiac | ||
| pacing lead. | For temporary connection of a | |
| pacing system analyser (PSA) or | ||
| temporary pace maker to a cardiac | ||
| pacing lead. | ||
| Indications for Use | To connect a pacing system | |
| analyser (PSA) or temporary pace | ||
| maker to a cardiac pacing lead. | To act as a conduit for the electrical | |
| signal generated from a Pacing | ||
| System Analyzer (PSA) or External | ||
| pacing Generator (EPG) to a | ||
| permanent pacemaker lead or | ||
| epicardial wire. | ||
| Statement | ||
| (ref. Proposed and | ||
| Predicate Device Labeling; | ||
| Appendix B) | ||
| Overall Cable Length | 2.5 meters / 8 feet | 2.5 meters / 8 feet |
| Lead Wire Cable | Alligator clips with color coded | |
| boots (black = negative; red = | ||
| positive) | Alligator clips with color coded | |
| boots (black = negative; red = | ||
| positive) | ||
| Connectors | ||
| Instrument Connector | "safe-connect" style | "safe-connect" style |
| Wire Type | 22-gauge metallic wire with | |
| plastic insulation | 22-gauge metallic wire with plastic | |
| insulation | ||
| Lead Compatibility | Single-Chamber Unipolar Leads; | |
| Single-Chamber Bipolar Leads; | ||
| Dual Chamber Unipolar Leads; | ||
| Dual Chamber Bipolar Leads | Single-Chamber Unipolar Leads; | |
| Single-Chamber Bipolar Leads: | ||
| Dual Chamber Unipolar Leads; | ||
| Dual Chamber Bipolar Leads | ||
| Performance Testing per | Yes | Yes |
| ANSI/AAMI EC53? | ||
| Sterile Device? | Yes | Yes |
| Sterilization Type | Ethylene Oxide | Ethylene Oxide |
| EO Sterilization Residuals | Per ISO 10993-7 | Per ISO 10993-7 |
| Disposable / Reusable | Disposable | Disposable |
| Shelf Life | 5 years | 3 years |
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510(k) Summary (K152947) - Page 3 of 3
Performance Testing:
Performance testing for the Tiger Medical Products Disposable Temporary Pacing Cable consists of physical integrity and electrical resistance in accordance with ANSI/AAMI EC53:2013 (dielectric withstand voltage, defibrillation withstand test, cable and leadwire noise, sink current, connector tensile strength, connector flex life testing, number of connector mate/unmate cycles, contact resistance, connector retention force and patient leadwire resistance). The Tiger Medical Products Disposable Temporary Pacing Cable has met all applicable acceptance criteria as defined in ANSVAAMI EC53:2013 with the exception of cable noise. The test results for cable noise were equivalent to the results of the same testing performed on the predicate device.
Conclusion:
The Tiger Medical Products Disposable Temporary Pacing Cable has been demonstrated to be substantially equivalent to the predicate device.