LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR

K971877 · Dideco S.P.A. · DTZ · Oct 8, 1997 · Cardiovascular

Device Facts

• Record ID: K971877
• Device Name: LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
• Applicant: Dideco S.P.A.
• Product Code: DTZ · Cardiovascular
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Dideco D902 Lilliput 2 Membrane Oxygenator is intended for use in infants less than 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 D 902 LILLIPUT 2 should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

Device Story

Dideco D902 Lilliput 2 is a membrane oxygenator with an integrated heat exchanger and venous reservoir. Device receives venous blood input during cardiopulmonary bypass surgery; performs gas exchange (oxygenation and CO2 removal) and blood temperature regulation (hypothermia/normothermia maintenance). Output is oxygenated blood returned to patient. Used in clinical surgical settings by perfusionists/surgeons. Benefits include support of extracorporeal circulation in infant patients during cardiac procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Membrane oxygenator with integrated heat exchanger and venous reservoir. Designed for extracorporeal circulation in infants < 20 kg. Operates via gas exchange and thermal transfer. Non-electronic, mechanical device.

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.”

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT 8 1997

Dideco, S.P.A. c/o Mr. Barry Sall Senior Regulatory Consultant Parexel International Corporation 1601 Trapelo Road Waltham, Massachusetts 02154

Re: K971877 Lilliput 2 Infant Hollow Fiber Oxygenator Requlatory Class: III (Three) Product Code: 74 DTZ Dated: August 25, 1997 August 26, 1997 Received:

Dear Mr. Sall:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Barry Sall

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callaha Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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870.4350- DTZ - DTZ - CPG Oxygenator

510(k) Number (if known): ____ 9 218 17_

Device Name: Dideco D902 Lilliput 2 Membrane Oxygenator

Indications For Use:

The Dideco D902 Lilliput 2 Membrane Oxygenator is intended for use in infants less than 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 D 902 LILLIPUT 2 should not be used longer than 6 hours.
Contact with blood for longer periods is not advised.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beta R. Rempelee

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K971877

V Prescritpion Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Otional format 1-2-96)

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