(15 days)
ECG pre-wired harnessed sets of electrodes for short and long term use; for adults, pediatrics and neonates.
By design and manufacturing process, the IP-SET® ECG electrodes are of multidisciplinary use, and the unit choice is performed by the Physician, in function of the desired application.
Set of disposable, single-use, pre-gelled ECG electrodes are regrouped on a flat cable sole or by pair (dual electrodes) and located to ease their positioning on the patient. Electrode number and positioning design vary according to the monitoring/diagnostics application.
Pre-gelled (hydro-gel) electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 90 mm in diameter or oblong / rectangular shape.
Lead wires are regrouped in a flat cable and are made of copper (radio-opaque) or carbon fiber (radio-translucent).
Sets are supplied non-sterile. Each set / harness is packaged in one OPP/PE laminated pouch (sealed foil); 10 to 50 pouches are supplied per box; Shipping cartons contain 12 boxes.
The provided document, K101685, is a 510(k) summary for Integral-Process's ECG Electrode "IP-SET®". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study on specific performance acceptance criteria. As such, it does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding specific acceptance criteria and detailed study results from a clinical trial or performance study.
The document primarily relies on comparisons to legally marketed predicate devices and compliance with relevant standards. Here's what can be inferred from the provided text regarding device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" (e.g., in terms of sensitivity, specificity, accuracy, or electrical performance thresholds) and reported device performance (e.g., percentages, mean improvements) from a dedicated study are provided. The device performance is generally stated as being "at least as well as other disposable ECG electrodes" based on comparison to predicate devices and compliance with standards.
| Acceptance Criteria Category | Acceptance Criteria (Not Explicitly Stated but Implied by Equivalence) | Reported Device Performance |
|---|---|---|
| Functionality | Equivalent to predicate devices (K944260, K944497) | "Identical in function" to Unomedical ECG monitoring electrodes. |
| Welding Process | Equivalent to predicate device (K003804) | "Identical welding process" to Sensi-Prema ECG monitoring electrode. Electrical and mechanical safety of connection "covered." |
| Electrical Safety | Cleared by predicate device (K011564) | "Cleared by predicate Neolead ECG electrode." |
| Biocompatibility | Cleared by predicate device (K011564) | "Cleared by predicate Neolead ECG electrode." |
| Overall Effectiveness | Safe and effective for intended use, performs as well as other disposable ECG electrodes. | "Safe and effective for their intended use and perform at least as well as other disposable ECG electrodes." |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document does not describe a performance study with a test set. Substantial equivalence is demonstrated through technological comparisons and compliance with relevant standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. There is no mention of a test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or reported. This device is an ECG electrode, not an AI or image-based diagnostic tool that would typically undergo an MRMC study to compare human reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only):
Not applicable. This device is a physical medical device (ECG electrode), not an algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used:
Not applicable. There is no mention of a primary ground truth established through expert consensus, pathology, or outcomes data. The "ground truth" for demonstrating substantial equivalence for this type of device relies on established performance characteristics of the predicate devices and compliance with recognized standards.
8. Sample Size for the Training Set:
Not applicable. This document pertains to the 510(k) clearance of a physical medical device (ECG electrode), not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
510(k) Summary
Administrative:
JUL -1 2010
| Submitter: |
|---|
| Integral-Process |
| Z.A. des Boutries |
| 12, rue des Cayennes, B.P. 310 |
| 78703 CONFLANS SAINTE HONORINE CEDEX, FRANCE |
| Tel: +33 1 39 72 66 66 - Fax: +33 1 39 72 61 61 |
Contact : Christian Berthon, Quality Manager, Official Correspondent Tel : +33 1 39 72 11 77 e-mail : cberthon@integral-process.com
Date of preparation: May 18, 2010
l Device Name:
Classification Name: Electrode, Electrocardiograph Common/Usual Name: ECG Electrode Proprietary Name: IP-SET®
| Classification: | Class II |
|---|---|
| Registration #: | 870.2360 |
| Product Code: | DRX |
ll Predicate Devices:
| SubstantialEquivalence | K # | Manufacturer / Currentmarketer | Device I/D(ECG Electrodes) |
|---|---|---|---|
| Functionality | MSB Ltd. (UK) -1994 | ||
| Diagnostics | K944260 | / Unomedical USA - 2008 | ECG Electrode - (0915M) |
| Other Monitoring appl. | K944497 | Unilect™, Monitab andBiotrace-HR (1014M) | |
| Manufacturing | NIKO Medical Products - 2000 | Sensi-prema neonatal ecg | |
| Ultrasonic welding | K003804 | / Unomedical USA - 2008 | electrodes - (45550) |
| ElectrodeComponents | |||
| Adhesive / hydrogel | K011564 | Neotech Products Inc. | Neolead |
��� Device Description:
Set of disposable, single-use, pre-gelled ECG electrodes are regrouped on a flat cable sole or by pair (dual electrodes) and located to ease their positioning on the patient. Electrode number and positioning design vary according to the monitoring/diagnostics application.
Pre-gelled (hydro-gel) electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 90 mm in diameter or oblong / rectangular shape.
Lead wires are regrouped in a flat cable and are made of copper (radio-opaque) or carbon fiber (radio-translucent).
Premarket notification: Integral-process, sets of ECG electrodes IP-SET®
page / or = 3
{1}------------------------------------------------
Sets are supplied non-sterile. Each set / harness is packaged in one OPP/PE laminated pouch (sealed foil); 10 to 50 pouches are supplied per box; Shipping cartons contain 12 boxes.
V Intended Use
ECG pre-wired harnessed sets of electrodes for short and long term use; for adults, pediatrics and neonates.
Follows a reference chart for most commonly suggested used (but not limited to) among which the Physician will determine which one is better suited for the desired application:
| IP-Set® P/N | Application | X Rays | Basic (B) /Combined(C) | Combination |
|---|---|---|---|---|
| 50502-US | Diagnostic | No | C | 50500-US +50503-US |
| 50505-US | Diagnostic | No | C | 50501-US +50504-US |
| 50506-US | Diagnostic | No | C | 50500-US +50510-US |
| 50507-US | Diagnostic | No | B | |
| 50510-US (*) | Used only in conjunctionwith P/N 50500-US forP/N 50506-US | No | B | |
| 50600-US | Coronary/X Rays | Yes | B | |
| 50601-US | Coronary/X Rays | Yes | B | |
| 50603-US | Coronary/X Rays | Yes | B | |
| 50604-US | Coronary/X Rays | Yes | B | |
| 50602-US | Coronary/X Rays | Yes | C | 50600-US +50603-US |
| 50605-US | Coronary/X Rays | Yes | C | 50601-US +50604-US |
| 50500-US | Monitoring | No | B | |
| 50501-US | Monitoring | No | B | |
| 50503-US | Monitoring | No | B | |
| 50504-US | Monitoring | No | B | |
| 50400-US | Pediatrics | Yes | B | |
| 50401-US | Neonat | Yes | B |
Nota: Ref # 50510-US is used for manufacturing only, and is always marketed in conjunction with ref # 50500-US under ref # 50506-US.
VI Comparison of Technological Characteristics
The Disposable, Single-Use, Pre-Wired and Pre-Gelled Integral-Process Sets of ECG Monitoring Electrodes IP-SET® are identical in function, and have the same intended use as the legally marketed disposable ECG monitoring range of electrodes Unilect™ for diagnostics (K944260) or other monitoring applications (K944497), manufactured today by Unomedical Ltd. (U.K.) and imported, marketed and distributed by Unomedical (USA) Inc. Unomedical is the new company name for MSB Itd (UK) which was granted both 510(k) marketing authorizations in reference.
The Disposable, Single-Use, Pre-Wired and Pre-Gelled Integral-Process Sets of ECG Monitoring Electrodes IP-SET® have the identical welding process of lead wire to electrode as performed for the legally marketed predicate Sensi-Prema ECG monitoring electrode granted to Maesrk/Niko medical under # K003804. The ultrasonic welding is in fact a proprietary process of Integral Process, technologically transferred to then Maersk Medical (UK), which became Unomedical
Premarket notification: Integral-process, sets of ECG electrodes IP-SET®
Page 2 of 3
{2}------------------------------------------------
Ltd. (see history). Therefore the pre wiring electrical and mechanical safety of the connection is covered.
Electrical safety and biocompatibility of skin-contact components have been cleared by predicate Neolead ECG electrode manufactured and legally marketed by Neotech Products Inc. under # K011564.
Other effectiveness and safety compliance to required standards and requirements are demonstrated in the market authorization file.
Accordingly Integral-Process concluded that the Disposable, Single-Use, Pre-Wired and Pre-Gelled Integral-Process Sets of ECG Electrodes IP-SET® are safe and effective for their intended use and perform at least as well as other disposable ECG electrodes.
Premarket notification: Integral-process, sets of ECG electrodes IP-SET®
Page 3 of 3
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Integral Process SAS, Z.A. des Boutries c/o Mr. Tamas Borsai TUV Rheinland of North America Responsible Third Party Official 12 Commerce Road Newtown, CT 06470
JUL -1 2010
Re: K101685
IP-SET®M3/IP-SET®M5/IP-SET®12, Models 50500-US/50501-US/50502-US; IP-SET®6V/IP-SET®5V/IP-SET®M12, Models 50503-US/50504-US/50505-US; IP-SET®12S/IP-SET®C, Models 50506-US/50507-US; IP-SET®M3RT/IP-SET®M5RT/ P-SET®M12RT/IP-SET®6VRT, Models 50600 US/50601-US/50602-US/50603-US: and IP-SET®5VRT/ IP-SET®M12RT/IP-SET®P3/IP-SET®N3, Models 50604-US/50605 US/50400-US/50401-US Regulatory Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: II (two) Product Code: 74 DRX Dated: May 3, 2010 Received: May 4, 2010
Dear Mr. Borsai:
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.
{4}------------------------------------------------
Page 2 - Mr. Tomas Borsai
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-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for 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/Resourcesfor You/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
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: IP-SET®, ECG Pre-Wired Sets of Electrodes
Indications For Use:
ECG pre-wired harnessed sets of electrodes for short and long term use; for adults, pediatrics and neonates.
By design and manufacturing process, the IP-SET® ECG electrodes are of multidisciplinary use, and the unit choice is performed by the Physician, in function of the desired application.
| IP-Set® P/N | Suggested Application(left to the Physician's discretion) | X Rays | Basic (B) /Combined (C) | Combination |
|---|---|---|---|---|
| 50502-US | Diagnostic | No | C | 50500-US + 50503-US |
| 50505-US | Diagnostic | No | C | 50501-US + 50504-US |
| 50506-US | Diagnostic | No | C | 50500-US + 50510-US |
| 50507-US | Diagnostic | No | B | |
| 50510-US (*) | Used only in conjunction withP/N 50500-US for P/N 50506-US | No | B | |
| 50600-US | Coronary/X Rays | Yes | B | |
| 50601-US | Coronary/X Rays | Yes | B | |
| 50603-US | Coronary/X Rays | Yes | B | |
| 50604-US | Coronary/X Rays | Yes | B | |
| 50602-US | Coronary/X Rays | Yes | C | 50600-US + 50603-US |
| 50605-US | Coronary/X Rays | Yes | C | 50601-US + 50604-US |
| 50500-US | Monitoring | No | B | |
| 50501-US | Monitoring | No | B | |
| 50503-US | Monitoring | No | B | |
| 50504-US | Monitoring | No | B | |
| 50400-US | Pediatrics | Yes | B | |
| 50401-US | Neonatal | Yes | B |
As per the reference chart:
Nota: Ref # 50510-US is used for manufacturing only, and is always marketed in conjunction with ref # 50500-US under ref # 50506-US
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C) ·
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number
Page 1 of
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.