IP-SET

K101685 · Integral Process Sas · DRX · Jul 1, 2010 · Cardiovascular

Device Facts

• Record ID: K101685
• Device Name: IP-SET
• Applicant: Integral Process Sas
• Product Code: DRX · Cardiovascular
• Decision Date: Jul 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended 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.

Device Story

IP-SET® consists of disposable, single-use, pre-gelled Ag/AgCl ECG electrodes arranged in harnessed sets on flat cables. Electrodes feature sensor elements (10-20 mm diameter) and adhesive bases (20-90 mm). Lead wires are copper (radio-opaque) or carbon fiber (radio-translucent). Used in clinical settings for ECG signal acquisition; physician selects specific model based on application (diagnostic, monitoring, coronary/X-ray). Device facilitates patient positioning via pre-grouped electrode sets. Output is raw ECG signal transmitted to external monitoring/diagnostic equipment. Benefits include ease of application and standardized electrode placement.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Disposable, single-use, pre-gelled Ag/AgCl electrodes. Sensor diameter 10-20 mm; adhesive diameter 20-90 mm. Lead wires: copper (radio-opaque) or carbon fiber (radio-translucent). Ultrasonic welding used for lead-to-electrode connection. Supplied non-sterile in OPP/PE laminated pouches.

Indications for Use

Indicated for short and long-term ECG monitoring and diagnostic applications in adult, pediatric, and neonatal patient populations.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ECG Electrode (0915M) (K944260)
• Unilect™, Monitab and Biotrace-HR (1014M) (K944497)
• Sensi-prema neonatal ecg electrodes (45550) (K003804)
• Neolead (K011564)

Submission Summary (Full Text)

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K101685

# 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: [phone] - Fax: [phone] |

Contact : Christian Berthon, Quality Manager, Official Correspondent Tel : [phone] e-mail : [e-mail]

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:

| Substantial<br>Equivalence | K # | Manufacturer / Current<br>marketer | Device I/D<br>(ECG Electrodes) |
|----------------------------|---------|------------------------------------|----------------------------------------------|
| Functionality | | MSB Ltd. (UK) -1994 | |
| Diagnostics | K944260 | / Unomedical USA - 2008 | ECG Electrode - (0915M) |
| Other Monitoring appl. | K944497 | | Unilect™, Monitab and<br>Biotrace-HR (1014M) |
| Manufacturing | | NIKO Medical Products - 2000 | Sensi-prema neonatal ecg |
| Ultrasonic welding | K003804 | / Unomedical USA - 2008 | electrodes - (45550) |
| Electrode<br>Components | | | |
| 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

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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) /<br>Combined<br>(C) | Combination |
|--------------|-------------------------------------------------------------------|--------|--------------------------------|------------------------|
| 50502-US | Diagnostic | No | C | 50500-US +<br>50503-US |
| 50505-US | Diagnostic | No | C | 50501-US +<br>50504-US |
| 50506-US | Diagnostic | No | C | 50500-US +<br>50510-US |
| 50507-US | Diagnostic | No | B | |
| 50510-US (*) | Used only in conjunction<br>with P/N 50500-US for<br>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 +<br>50603-US |
| 50605-US | Coronary/X Rays | Yes | C | 50601-US +<br>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

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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®

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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.

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## 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 [phone] or [phone] 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

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K101685

## 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<br>(left to the Physician's discretion) | X Rays | Basic (B) /<br>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 with<br>P/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

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