Who is the manufacturer of CHASE MULTIPLE PERFUSION SET?

Chase Medical, Inc. filed the 510(k) submission for CHASE MULTIPLE PERFUSION SET (K964200).

What is the FDA product code for CHASE MULTIPLE PERFUSION SET?

DWF. It is classified under 21 CFR 870.4210 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CHASE MULTIPLE PERFUSION SET?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CHASE MULTIPLE PERFUSION SET?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CHASE MULTIPLE PERFUSION SET

Q: What are the predicate devices for CHASE MULTIPLE PERFUSION SET?

DLP, Inc. Multiple Perfusion Set (K791498).

K964200 · Chase Medical, Inc. · DWF · Apr 16, 1997 · Cardiovascular

Device Facts

Record ID	K964200
Device Name	CHASE MULTIPLE PERFUSION SET
Applicant	Chase Medical, Inc.
Product Code	DWF · Cardiovascular
Decision Date	Apr 16, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4210
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Chase Medical multiple perfusion sets are intended for use in conjunction with cardiopulmonary bypass surgery for simultaneous perfusion of the aortic root and 3 or 4 vein grafts.

Device Story

Device used during open-heart surgery; facilitates simultaneous delivery of cardioplegia solution to aortic root and 3 or 4 vein grafts. Surgeon connects set to perfusion equipment; cardioplegia solution infused to stop and preserve heart. Device ensures bloodless, still surgical field. Benefits patient by enabling precise, simultaneous myocardial protection during bypass.

Clinical Evidence

Bench testing only. Testing included leak testing at 10 psi (4°C and 40°C), tubing bond strength (>10 lb tensile), luer connection compliance (ANSI/HIMA MD70.1-1983), package integrity (ASTM F1140-88), and shipping/vibration/drop testing. Two-year shelf life validated via accelerated aging.

Technological Characteristics

Materials identical to predicate. Luer connections compliant with ANSI/HIMA MD70.1-1983. Packaging tested per ASTM F1140-88. Sterilization via 100% Ethylene Oxide (Overkill Method, SAL 10⁻⁶).

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring simultaneous cardioplegia delivery to the aortic root and 3 or 4 vein grafts.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

DLP, Inc. Multiple Perfusion Set (K791498)

Related Devices

K964198 — CAHSE AORTIC ROOT CANNULA · Chase Medical, Inc. · Mar 19, 1997
K971041 — CHASE CORONARY OSTIAL PERFUSION CANNULA · Chase Medical, Inc. · May 13, 1997
K972503 — CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE · Sorin Group Italia S.R.L. · Aug 26, 1997
K962510 — HEARTPORT ENDOAORTIC CLAMP · Heartport, Inc. · Sep 11, 1996
K034058 — SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 · Medtronic Vascular · Jan 29, 2004

Submission Summary (Full Text)

{0} K964000 APR 16 1997 510K Summary # Chase Medical Multiple Perfusion Set ## I. General Information A. Generic Name: Multiple Perfusion Set B. Trade Name of Device: Chase Multiple Perfusion Set C. Applicant's Name and Address: Chase Medical Inc. 1876 Firman Drive. Richardson, Texas 75081 D. Pre-market Notification Number: Not yet assigned ## II. Indications for Use Chase Medical multiple perfusion sets are intended for use in conjunction with cardiopulmonary bypass surgery for simultaneous perfusion of the aortic root and 3 or 4 vein grafts. ## III. Device Description During open-heart surgery, the patient’s heart is temporarily stopped to allow the surgeon a bloodless, still surface in order to complete the surgical repair. The process of stopping the heart is often achieved by infusing into the heart a solution containing various drugs which act to stop and preserve the heart. This cardioplegia solution is delivered into the heart by way of the aorta and/or into vein grafts. The multiple perfusion set allows the simultaneous perfusion of cardioplegia into the aortic root and vein grafts. ## IV. Device Classification: Class II ## V. Safety and Effectiveness Substantial Equivalence: The device is substantially equivalent to the DLP, Inc. Multiple Perfusion Set # K791498. ## VI. Other Safety and Effectiveness Data Materials: All material are identical to the predicate device. Sterilization: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶ ## Functional Testing All functional characteristics of the Chase Medical multiple perfusion set are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition. {1} # SUMMARY OF SAFETY AND EFFECTIVENESS | Leak Test Requirements: | No leaks at 10 psi air on Chase device at 4°C and 40°C | | --- | --- | | Tubing Bond Strength: | Exceeds 10 lb. tensile strength @ 4°C and 40°C | | Luer Connections: | Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings | | Package Integrity: | Tyvek/Polymylar passed burst test per ASTM F1140-88 | | Shipping & Distribution Testing: | Per National Safe Transit Ass. vibration and drop tests | | Accelerated Aging: | Two year shelf life |