(61 days)
The Unimed Disposable ECG Lead Wires are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.
The unimed disposable ECG lead wire is a single patient electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.
The provided document is a 510(k) premarket notification for the "Unimed Disposable ECG Lead Wires". It describes the device, its intended use, a comparison to a predicate device, and performance data from adherence to recognized standards. However, it does not contain the specific information required to answer the prompt in detail, such as acceptance criteria in a table format, specific details of a study (sample size, data provenance, ground truth establishment, expert roles, adjudication methods), or any MRMC comparative effectiveness study results.
This document describes a device used to transmit cardiac signals, not an AI or imaging device, so many of the requested criteria (like multi-reader multi-case studies, ground truth establishment for algorithms, training sets, etc.) are not applicable to this type of medical device submission.
Based only on the provided text, here is what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical targets and corresponding device performance results. Instead, it states that the device "meets the requirements of EC53 and IEC60601-1" and "meets the following the recognized standards." This indicates compliance with the standards are the acceptance criteria for performance, but the specific metrics and values are not detailed in this submission.
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance |
|---|---|
| ANSI/ANMM EC53-1995 (R)2001, R(2008) ECG Cables and Leadwires (except4.3.1) | Device meets requirements of this standard. |
| ANSI/AAMI EC13 Cardiac monitors, heart rate meters and alarms (only product markings, chapter 4.1.1.5),2002 | Device meets requirements of this standard. |
| FR 898: Guidance Document on the Performance Standard for Electrode Lead Wires and Patient Cables, May 11, 1998 | Device meets requirements of this standard. |
| IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995 | Device meets requirements of this standard. |
| ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009 | Device meets requirements of this standard. |
| ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010 | Device meets requirements of this standard. |
Regarding the study that proves the device meets the acceptance criteria:
The document states that "performance data" was submitted to demonstrate substantial equivalence and adherence to the listed standards. However, it does not describe a "study" in the typical clinical trial sense with the requested details. The performance data seems to refer to engineering testing and biocompatibility assessments to confirm compliance with the technical standards.
Due to the nature of this device (an ECG lead wire, essentially a cable), many of the questions are not directly applicable. I will answer the remaining questions with "Not Applicable" or "Not Provided" where the information is not present in the given text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not provided. This would typically refer to the number of devices tested to meet the standards, or potentially the number of subjects if clinical performance was explicitly tested beyond standard adherence, but such detail is absent.
- Data Provenance: Not provided. The manufacturing country is China, but the origin of any test data is not specified.
- Retrospective or Prospective: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is not an AI or diagnostic imaging device that requires expert interpretation for ground truth establishment. Device performance is assessed against technical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication is mentioned or implied for the performance testing of an ECG lead wire against technical standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is an ECG lead wire, not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's performance is adherence to the specifications and performance requirements outlined in the cited engineering and biocompatibility standards.
8. The sample size for the training set
- Not Applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI device that requires a training set.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2014
Unimed Medical Supplies, Inc. Ms. Tan Xinmei QA & RA Manager No.37, Yanshan Road, Shekou Shenzhen, 518067 China
K142489 Re:
Trade/Device Name: Unimed Disposable ECG Lead Wires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: August 10, 2014 Received: September 4, 2014
Dear Ms. Tan Xinmei.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,
M.A. Hilleman
for
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page __ 1__ of___ 1_
510(k) Number (if known): __K142489
Device Name: Unimed Disposable ECG Lead Wires
Indications for Use
The Unimed Disposable ECG Lead Wires are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.
Model:
| HT3-90DS | DG5-90DS | SMB3-90DP | HPA5-90DP | 2385DS | MR5-90DS | AP5-90DS |
|---|---|---|---|---|---|---|
| MQ3-90DS | NKB6-90DS | D3-90DS | AAB5-90DS DT5-90DS | 2586DP | MQB6-90DS | |
| AAB3-90DP | AP6-90DS | DG3-90DP | AT5-90DP | MR5-90DP DT3-90DS | DG6-90DS | |
| AT3-90DS | 2396DS | 2386DP | HT5-90DS | SM5-90DS | 2585DP | NKB3-90DS |
| D5-90DP | AP3-90DP | 2596DS | 2312DP | 2512DP | HP3-90DS I | MQ5-90DS |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use x (Per 21 CFR 801.109)
Over-The-Counter Use
OR
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K142489
Page 1 of 5
510(K) Summary
Prepared Date: 2014-8-15
1. Submitter Information
| Name | Unimed Medical Supplies Inc |
|---|---|
| Address | No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 |
| Tel | +86-755 26695165 |
| Fax | +86-755 26697984 |
| EstablishmentRegistration No. | 3007307487 |
2. Contact Person
| Contact person | Tan xinmei |
|---|---|
| Title | QA&RA manager |
| Address | No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 |
| Tel | +86-755 26695165 |
| Fax | +86-755 26697984 |
| tanxinmei@unimed.cn |
3. Manufacturer Information
| Name | Unimed Medical Supplies Inc |
|---|---|
| Address | No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 |
| Establishment | 3007307487 |
| Registration No. |
4. Proposed Device Information
| Trade Name | Unimed Disposable ECG lead wires |
|---|---|
| Common name | ECG lead wires |
| Classification name | Patient transducer and electrode cable (including connector) |
| Regulatory class | Class 2 |
| Productionregulation | 21 CFR § 870.2900 |
| Product code | DSA |
| Panel | Cardiovascular |
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Part 2 of 5
| 510(K)No. | K110287 |
|---|---|
| Submitter's Name | Philips Medical Systems |
| Trade Name | Philips ECG Leadwire Set |
| Common name | ECG Leadwire Set |
| Classification name | Patient transducer and electrode cable (including connector) |
| Regulatory class | Class 2 |
| Production regulation | 21 CFR § 870.2900 |
| Product code | DSA |
| Panel | Cardiovascular |
5. Predicate Device Information
6. Device description
The unimed disposable ECG lead wire is a single patient electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.
7. Intended use
The subject device are intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. These leadwires are intended for short-term use only (an average patient stay of 5 days).
| Comparisonitem | Subject DeviceUnimed | Predicate DeviceK110287 | Note |
|---|---|---|---|
| Intended use | The subject device areintended for use only bytrained healthcareprofessionals formeasurement of a patient'sECG for both diagnostic andmonitoring purposes. Use is | Philips Single-Patient-UseDisposable ECG Leadsets areintended for use only bytrainedhealthcare professionals formeasurement of a patient'sECG for both diagnostic and | Same |
| limited by the indications foruse of the connectedmonitoring or diagnosticequipment. These leadwiresare intended for short-termuse only (an average patientstay of 5 days). | monitoring purposes. Use islimited by the indications foruse of the connectedmonitoring or diagnosticequipment. These Philipsleadsets are intended forshort-termuse only (an average patientstay of 5 days). | ||
| Indicationsfor Use | The subject device areindicated for use in themonitoring of cardiac signalsfor bothdiagnostic and monitoringpurposes. Use is limited bythe indications for use of theconnected monitoring ordiagnostic equipment. | Philips ECG leadsets areindicated for use in themonitoring of cardiac signalsfor bothdiagnostic and monitoringpurposes. Use is limited bythe indications for use of theconnected monitoring ordiagnostic equipment. | Same |
| AnatomicalSites | Attached to electrodes placedat standard specifiedlocations on chest wall andextremities | Attached to electrodes placedat standard specifiedlocations on chest wall andextremities | Same |
| Design/Appearance | Cables with "grabber/snap"configuration of ECGelectrode connector (distalconnector) and common"header" connection(proximal connector) | Cables with "grabber"configuration of ECGelectrode connector (distalconnector) and common"header" connection(proximal connector) | Same |
| Sterility | Supplied non-sterile;cannotbe sterilized or otherwisereprocessed | Supplied non-sterile;cannot besterilized or otherwisereprocessed | Same |
| Usage | Single patient use | Single patient use | Same |
| Material | PA66,PVC,ABS | PA66,PVC,ABS | Same |
| Cable Length | 0.9m/3.4m | 1.0m/0.85m | Similar |
| CableConstruction | Flexible shielded multiconductor electrical cable | Flexible shielded multiconductor electrical cable | Same |
| Wire Color | White | White | Same |
| LeadwireConstruction | Shielded copper leadwirewith polymerjacket | Ribbonized leads withindividual coax shields | Same |
| Lead number | 3,5&6 | 3,5 | Similar |
| ProximalconnectorDesign | Compatible to MultiLinkyoke design | Compatible to MultiLinkyoke design | Same |
| DistalconnectorDesign | "Grabber"or"Snap"electrodeconnectors are labeledLL(red),RA(white),RL(green),LA(black)&,V(brown) | "Grabber" electrodeconnectors are color coded(red, white, green, coded(red, white, green,black, brown)Connector designations(LL,RL etc.) moldedinto plastic | Similar |
| Conformancestandard | IEC60601-1(Safety)EC53(Performance)ISO10993-5,-10(Biocompatibility ) | IEC60601-1(Safety)EC53(Performance)ISO10993-5,-10(Biocompatibility) | Same |
8. Comparison to predicate device
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From the comparison form above, both devices have the same intended use ,indications for use, Anatomical Sites, Design /Appearance, Sterility, Usage, Material,Cable Construction, Wire Color& Conformance standard,have the similar cable length, Lead number& Distal connector Design item.
But in cable length, Lead number& Distal connector Design item,both devices have some difference, please see the following analysis.
Note1 Cable Length
The subject devices is longter than philips unit,but unimed units meet the requirements of EC53 and IEC60601-1, so this difference does not bring any safety and effectiveness problem.
Note2 Lead number
The subject devices have 6 lead type which fit the clinical use. Meanwhile the subject units meet the requirements of EC53 and IEC60601-1, so this difference also does not bring any safety and effectiveness problem.
Note3 Distal connector Design
In this item,the suject device have grabber type and snap type ,which is more suitable for clinical use.Futhermore, the subject devices meet the requirements of EC53 and IEC60601-1, so this difference also does not bring any safety and effectiveness problem.
9. Performance data
The subject device meets the following the recognized standards:
- ANSI/ANMM EC53-1995 (R)2001, R(2008) ECG Cables and Leadwires (except4.3.1)
- ANSI/AAMI EC13 Cardiac monitors, heart rate meters and alarms (only product markings, chapter 4.1.1.5),2002
- FR 898: Guidance Document on the Performance Standard for Electrode Lead Wires and Patient Cables, May 11, 1998
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K142489 Part 5 of 5
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010
10. Substantial Equivalence Statement
Based on the comparison ,analysis, and the submitted performance data, unimed believes that the unimed disposable ECG Lead Wire is as safe and effective and is substantially equivalent to the predicate devices.
§ 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).