LILLIPUP PMP, LILLIPUT PMP INTEGRATED

K151713 · Sorin Group Italia S.R.L. · DTZ · Nov 6, 2015 · Cardiovascular

Device Facts

• Record ID: K151713
• Device Name: LILLIPUP PMP, LILLIPUT PMP INTEGRATED
• Applicant: Sorin Group Italia S.R.L.
• Product Code: DTZ · Cardiovascular
• Decision Date: Nov 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The device is intended for use in infants not exceeding 20 Kg (44 lb) who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir is intended to collect blood during normal operation, to always assure the proper oxygenation capability of the device. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

Device Story

Lilliput PMP is a hollow fiber membrane oxygenator with an integrated heat exchanger; used during cardiopulmonary bypass surgery for infants ≤ 20 kg. Device receives venous blood as input; performs gas exchange (oxygenation/CO2 removal) and temperature regulation via heat exchanger. Operates at flow rates up to 2.3 L/min. Available as standalone oxygenator or integrated with a venous reservoir (Lilliput PMP Integrated). Used in clinical settings by perfusionists/surgeons. Output provides oxygenated blood to patient; assists in maintaining normothermia or inducing hypothermia. Benefits include effective extracorporeal circulation and blood temperature control during pediatric cardiac procedures.

Clinical Evidence

Bench testing only. In vitro studies conducted per FDA guidance for cardiopulmonary bypass oxygenators. Evaluated blood trauma, biological activity, coating leaching, surface integrity/coverage, blood volume capacity, oxygenating performance, pressure drops, pathway integrity, and plasma leakage. All tests met acceptance criteria.

Technological Characteristics

Hollow fiber membrane oxygenator with integrated heat exchanger. Oxygenating fiber: polymethylpentene (PMP), surface area ~0.80 m². Priming volume ≤140 ml. Flow rate up to 2.3 L/min. Ethylene oxide sterilized. Single-use. Non-pyrogenic fluid path. Materials consistent with predicate except for fiber type.

Indications for Use

Indicated for infants ≤ 20 kg (44 lb) undergoing cardiopulmonary bypass surgery requiring extracorporeal circulation. Contraindicated for use longer than 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”

Predicate Devices

• D902 Lilliput Ph.I.S.I.O. (K001021)

Reference Devices

• Venomidicard reservoir (K941215)

Submission Summary (Full Text)

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#### 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

November 06, 2015

Sorin Group Italia S.r.1. % Barry Sall Principal Consultant Parexel Consulting LLC 195 West Street Waltham, Massachusetts 02451

Re: K151713

Trade/Device Name: Lillipup PMP, Lilliput PMP Integrated Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: October 7, 2015 Received: October 8, 2015

Dear Barry Sall:

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M.A. Hillebrenner

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Form Approved: OMB No. 0910-0120

| Form Approved: OMB No. | 0910-0120 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. | |
| 510(k) Number (if known) | K151713 |
| Device Name | Lilliput PMP<br>Lilliput PMP Integrated |
| Indications for Use (Describe) | Patient Population: Infants not exceeding 20 Kg (44 lb) |
| The device is intended for use in infants not exceeding 20 Kg (44 lb) who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir is intended to collect blood during normal operation, to always assure the proper oxygenation capability of the device. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised. | |
| Type of Use (Select one or both, as applicable) | <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br>[e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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### 510(k) SUMMARY

| SUBMITTER: | Sorin Group Italia<br>86, Via Statale 12 Nord<br>41037 Mirandola (MO) Italy |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | June 24, 2015 |
| DEVICE TRADE NAMES: | Lilliput PMP<br>Lilliput PMP Integrated |
| COMMON NAMES: | Hollow Fiber Oxygenator<br>Hollow Fiber Oxygenator/Reservoir |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator/<br>Cardiopulmonary Bypass Heat Exchanger<br>Cardiopulmonary Bypass Blood Reservoir.<br>Cardiopulmonary Bypass Defoamer |
| CLASSIFICATION CODE: | DTZ |
| REGULATION NUMBER: | 870.4350 |
| PREDICATE DEVICE(S): | D902 Lilliput Ph.I.S.I.O. (K001021) |

#### DEVICE DESCRIPTION:

The Lilliput PMP is a high efficiency hollow fiber diffusion membrane oxygenator with integrated heat exchanger.

The device provides oxygenation and carbon dioxide removal from patient's blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia, or aids in the maintenance of normothermia during surgery.

The device can be operated at flow rates up to 2.3 liters per minute (I/min).

The Lilliput PMP is a modified version of the currently marketed D902 Lilliput Ph.I.S.I.O.

The device is offered as a standalone oxygenator module (Lilliput PMP). Similar to the predicate device, the oxygenator module can be connected with, but not limited to, the Venomidicard reservoir (K941215). This combined configuration (oxygenator module connected with the reservoir) is labeled as Lilliput PMP Integrated.

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### INDICATION FOR USE:

As for the predicate device the indication for use covers both configurations (Lilliput PMP and Lilliput PMP Integrated) and is the following:

The device is intended for use in infants not exceeding 20 Kg (44 lb) who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir is intended to collect blood during normal operation, to always assure the proper oxygenation capability of the device. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

#### TECHNOLOGICAL CHARACTERISTICS:

The PMP devices have the same fundamental technological characteristics, principles of operation and control mechanisms as the predicate device.

The PMP devices include a different oxygenating fiber consisting of polymethylpentene (PMP, surface area approx. 0.80 m²) rather than the polypropylene fiber (PP, surface area approx. 0.64 m²) used for the predicate device. As a result, the static priming volume is ≤140 ml rather than ≤155 ml.

No other changes have been made to the device. The reservoir has not been modified and is not subject of the present 510(k).

Except for the change of the oxygenating fiber, the PMP devices utilize the same materials as the predicate device.

No change to the intended use has been made as a result of these modifications.

The devices are substantially equivalent to the predicate device on the basis of operating principles and basic function.

There are no differences in packaging design with respect to the predicate device.

The PMP devices are ethylene oxide sterilized and have a non-pyrogenic fluid path. They are for single use only.

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## NON CLINICAL TEST RESULTS:

Applicable tests were conducted in accordance with the requirements of ISO 10993-1. The current draft Guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and its guidelines was also considered limited to external communicating device, circulating blood, limited contact duration.

# IN VITRO TEST RESULTS:

In vitro testing was conducted on the Lilliput PMP only since the oxygenating module is the single device element subject to modifications with respect to the predicate device. The tests were performed to demonstrate predicate device substantial equivalency and compliance to safety and effectiveness requirements.

The tests were conducted in accordance with the relevant requirements of "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000".

For the reservoir, the performance data previously submitted and already cleared are cross referenced.

The following table lists the performance tests conducted to demonstrate compliance of Lilliput PMP to the product's performance specifications and predicate device substantial equivalency. The Lilliput PMP successfully met all acceptance criteria for each of the following tests:

- Blood trauma —
- Biological activity —
- Leaching of coating |
- Surface modification integrity —
- Surface modification coverage -
- Blood volume capacity -
- Oxygenating performance/blood side pressure drops -
- Blood, water, gas pathway integrity -
- -Plasma leakage

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## CONCLUSIONS:

The results of in vitro studies demonstrated that the modified device performs in a manner substantially equivalent to the predicate device with respect to the relevant functional parameters.

Test results of this study demonstrate the predicate device substantial equivalence with respect to device function.

Additional testing has also demonstrated the effectiveness of production techniques to assure that the device is sterile and non-pyrogenic.