(66 days)
Not Found
No
The document describes a simple ECG cable used for signal transmission and does not mention any AI/ML capabilities or processing of the signals beyond transmission.
No
The device is described as transmitting ECG signals for diagnostic and monitoring purposes, not for treating any medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the ECG cable is used "for both diagnostic and monitoring purposes."
No
The device is described as a physical cable with leadwires and clips, which are hardware components used to transmit electrical signals. The performance studies also focus on hardware-related testing like electrical safety, biocompatibility, and mechanical specifications.
Based on the provided information, the Fixed Patient Leads ECG Cable is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The ECG cable's function is to transmit electrical signals from electrodes placed on the patient's body to a monitoring or diagnostic system. It does not analyze or process specimens from the body.
- Intended Use: The intended use is to transmit signals for diagnostic and monitoring purposes, but the diagnostic process itself happens within the connected equipment, not the cable.
- Device Description: The description clearly states it's an external device that transmits signals from electrodes affixed to the patient's body.
Therefore, the ECG cable is a medical device used in conjunction with diagnostic equipment, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The Fixed Patient Leads ECG Cable is used to transmit signals from patient-connected electrodes or transducers to electrocardiograph recorders/monitors for both diagnostic and monitoring purposes.
ECG cables are supplied non-sterilizable; they are reusable devices and are intended for use by trained operators in a medical environment. Usage is limited to the indications for use of the connected monitoring or dagnostic equipment.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
The BSC Model 3153 ECG Cable is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body to an external BSC programming system display monitor. One end of each leadwire clip is attached to an ECG patient electrode; the other end is affixed / molded into one end of the trunk cable. The trunk cable then plugs into the BSC programming system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Attached to electrodes placed at standard specified locations on chest wall and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained operators in a medical environment.
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)
Component Qualification, Electrical Device Verification Testing (DVT) (including Electromagnetic Immunity / Electromagnetic Compatibility (EMI / EMC), Electrical Safety, and general functional testing), Biocompatibility Assessment, and a Packaging Assessment were performed to support a determination of substantial equivalence.
Design Verification Testing conducted to support this submission demonstrated that all requirements were met. Component Qualification verified the ability for Affinity to provide ECG Cables that meet BSC mechanical and electrical specifications, as well as functionality / performance requirements. Electrical DVT verified that the Model 3300 Programmer and associated cables, including the proposed ECG Cable, meet system electrical design specifications.
Design Validation Testing conducted on the proposed ECG Cable demonstrated that the cable meets user needs and its intended use. Results of Biocompatibility Testing demonstrated that the ECG Cable is biocompatible for its intended use.
Design Analysis and Evaluation Testing evaluated device robustness and correct implementation of the design intent. Results of the Packaging Assessment demonstrated that Affinity-manufactured ECG Cable box labels meet adhesion, legibility, and indelibility requirements.
Results of this testing provide reasonable assurance that the proposed device design meets the performance requirements and performs as intended.
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.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 3, 2017
Boston Scientific Corporation Elizabeth Lisowski Principal Regulatory Affairs Specialist 4100 Hamline Avenue North St. Paul, Minnesota 55112
Re: K172591
Trade/Device Name: Fixed Patient Leads ECG Cable (Model 3153) Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: October 4, 2017 Received: October 5, 2017
Dear Elizabeth Lisowski:
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Willemen
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172591
Device Name Fixed Patient Leads ECG Cable (Model 3153)
Indications for Use (Describe)
The Fixed Patient Leads ECG Cable is used to transmit signals from patient-connected electrodes or transducers to electrocardiograph recorders/monitors for both diagnostic and monitoring purposes.
ECG cables are supplied non-sterilizable; they are reusable devices and are intended for use by trained operators in a medical environment. Usage is limited to the indications for use of the connected monitoring or dagnostic equipment.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
1. GENERAL INFORMATION
| Device Common / Usual
| Generic Name: | ECG Cable |
|---|---|
| Device Trade Name: | Fixed Patient Leads ECG Cable (Model 3153) |
| Applicant's Name and | |
| Address: | Boston Scientific Corporation |
| 4100 Hamline Avenue North | |
| St. Paul, Minnesota 55112-5798 | |
| FDA Registration Establishment No. 2124215 | |
| Product Code / | |
| Regulation Citation: | DSA, Cardiovascular / 21 CFR Part §870.2900 |
| The ECG Cable is a Class II device as defined in 21 CFR Part | |
| §870.2900 and has a product code of DSA | |
| Panel: 74 Cardiovascular | |
| Contact Name and | |
| Information: | Elizabeth A. Lisowski |
| Principal Regulatory Specialist | |
| Phone: 651-532-5131 | |
| Fax: 651-582-5134 | |
| E-mail: beth.lisowski@bsci.com | |
| Owner / Operator: | Boston Scientific Corporation |
| One Boston Scientific Place | |
| Natick, Massachusetts 01760 | |
| FDA Registration Establishment No: 9912058 | |
| Manufacturing Facility: | Affinity Medical Technologies |
| 3545 Harbor Boulevard | |
| Costa Mesa, California 92626 | |
| FDA Registration Establishment No: 2031044 |
2. DEVICE
Fixed Patient Leads ECG Cable (Model 3153)
3. PREDICATE DEVICE
Removable Patient Leads ECG Cable (K132253; cleared December 16, 2013)
DEVICE DESCRIPTION 4.
The BSC Model 3153 ECG Cable is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body to an external BSC programming system display monitor. One end of each leadwire clip is attached to an ECG patient electrode; the other end is affixed / molded into one end of the trunk cable. The trunk cable then plugs into the BSC programming system. K172591 Pg. 1 of 4
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5. INDICATIONS FOR USE
The Fixed Patient Leads ECG Cable is used to transmit signals from patient-connected electrodes or transducers to electrocardiograph recorders / monitors for both diagnostic and monitoring purposes.
ECG cables are supplied non-sterile and are not sterilizable; they are reusable devices and are intended for use by trained operators in a medical environment. Usage is limited to the indications for use of the connected monitoring or diagnostic equipment.
DEVICE COMPARISON TO PREDICATE 6.
The BSC ECG cable incorporates substantially equivalent design, packaging, fundamental technology, and Indications for Use as the predicate ECG Cable (Removable Patient Leads ECG Cable; K132253). Refer to Table 1 for a comparison between the BSC Fixed Patient Leads ECG Cable and the BSC Predicate Removable Patient Leads ECG Cable.
| Characteristic | Proposed BSC Fixed Patient Leads
ECG Cable | Predicate BSC Removable Patient
Leads ECG Cable |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | ECG Cable is used to transmit signals
from patient-connected electrodes or
transducers to electrocardiograph
recorders / monitors for both
diagnostic and monitoring purposes. | ECG Cable is used to transmit signals
from patient-connected electrodes or
transducers to electrocardiograph
recorders / monitors for both diagnostic
and monitoring purposes. |
| Patient Usage | Reusable | Reusable |
| Sterility | Supplied non-sterile; cannot be
sterilized | Supplied non-sterile; cannot be
sterilized |
| Anatomical Sites | Attached to electrodes placed at
standard specified locations on chest
wall and extremities | Attached to electrodes placed at
standard specified locations on chest
wall and extremities |
| Design / Appearance / Functionality | | |
| Functionality | Transmits signals from 5 patient-
connected leadwires | Transmits signals from 5 patient-
connected leadwires |
| No. of Leadwires
(Patient Wire) | 5 | 5 |
| Leadwire / Trunk
Cable Joint | Fixed | Removable |
| Trunk Cable Length
(from edge of yoke to
edge of patient clip) | $80\pm2"$ | $120\pm6"$ |
| Leadwire Length
(each) | $30\pm2"$ | $40\pm1.5"$ |
| Connector - Patient
End | Patient Clip | Patient Clip |
| Connector - Monitor
End | 6 pin DIN AAMI | 6 pin DIN AAMI |
| Table 1: Comparison between BSC Fixed Patient Leads ECG Cable and BSC Predicate | ||
|---|---|---|
| Removable Patient Leads ECG Cable. |
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| Characteristic | Proposed BSC Fixed Patient Leads
ECG Cable | Predicate BSC Removable Patient
Leads ECG Cable |
|-------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Materials | Biocompatible per 10993-1 | Biocompatible per 10993-1 |
| Leadwire Colors
(IEC 60601-2-27) | White Red
Green Black
Brown | White Red
Green Black
Brown |
| Packaging | Outer labeled box
Inner labeled bubble pouch
Non-sterile | Outer labeled box
Inner labeled bubble pouch
Non-sterile |
7. PERFORMANCE DATA
Component Qualification, Electrical Device Verification Testing (DVT) (including Electromagnetic Immunity / Electromagnetic Compatibility (EMI / EMC), Electrical Safety, and general functional testing), Biocompatibility Assessment, and a Packaging Assessment were performed to support a determination of substantial equivalence.
Design Verification Testing conducted to support this submission demonstrated that all requirements were met. Component Qualification verified the ability for Affinity to provide ECG Cables that meet BSC mechanical and electrical specifications, as well as functionality / performance requirements. Electrical DVT verified that the Model 3300 Programmer and associated cables, including the proposed ECG Cable, meet system electrical design specifications.
Design Validation Testing conducted on the proposed ECG Cable demonstrated that the cable meets user needs and its intended use. Results of Biocompatibility Testing demonstrated that the ECG Cable is biocompatible for its intended use.
Design Analysis and Evaluation Testing evaluated device robustness and correct implementation of the design intent. Results of the Packaging Assessment demonstrated that Affinity-manufactured ECG Cable box labels meet adhesion, legibility, and indelibility requirements.
Standards applicable to the proposed ECG Cable:
- ANSI/AAMI EC53:2013: ECG trunk cables and patient leadwires ●
- IEC 60601-1:2005: Medical electrical equipment Part 1: General requirements for ● basic safety and essential performance
- IEC 60601-1-2:2014: Medical electrical equipment Part 1-2: General requirements . for safety - Collateral standard: Electromagnetic compatibility - requirements and tests
Standards used to perform Biocompatibility Testing:
- . EN ISO 10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
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- EN ISO 10993-10:2013: Biological evaluation of medical devices Part 10: Tests for ● irritation and skin sensitization
Results of this testing provide reasonable assurance that the proposed device design meets the performance requirements and performs as intended.
CONCLUSION 8.
Based on the Indications for Use, technological characteristics, and safety and performance testing, the BSC Fixed Patient Leads ECG Cable has been shown to be appropriate for its Indications for Use and is considered to be substantially equivalent to the predicate BSC Removable Patient Leads ECG Cable cleared by FDA on December 16, 2013 (K132253).