The Optima XP™ is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

Device Description

The Optima XP™ is a hollow fiber membrane oxygenator with integral heat exchanger. Used in coniunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's gas exchange and body temperature regulation requirements during surgical procedures,

The product is sterilized by ethylene oxide gas and has nonpyrogenic fluid pathways.

AI/ML Overview

Here's an analysis of the provided text regarding the Optima XP device, structured according to your request:

Acceptance Criteria and Device Performance Study for Optima XP

The Optima XP is a hollow fiber membrane oxygenator with an integral heat exchanger, intended for adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. The key modification from its predicate device, the Optima, is an increase in membrane surface area achieved by decreasing fiber diameter and increasing fiber count.

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are implicitly defined by the goal of the device modification and comparisons to its PREDICATE DEVICE (COBE® Optima TM Hollow Fiber Membrane Oxygenator).

Acceptance Criteria Category	Specific Criteria/Performance Aspect	Reported Device Performance (Optima XP vs. Optima)
Oxygen Transfer Rate	Increased oxygen transfer compared to the Optima	Increased oxygen transfer rate
Operating Volume	Corresponding increase in operating volume is acceptable	Higher operating volume (deemed acceptable)
Gas Side Pressure Drop	Corresponding increase in gas side pressure drop is acceptable	Higher gas side pressure drop (deemed acceptable)
Carbon Dioxide Transfer	No significant difference compared to the Optima	Not significantly different
Blood Pathway Pressure	No significant difference compared to the Optima	Not significantly different
Unrecoverable Volume	No significant difference compared to the Optima	Not significantly different
Blood Trauma	No significant difference compared to the Optima	Not significantly different
Heat Exchanger	Identical design, manufacture, and installation to predicate	Identical; not evaluated for this 510(k) as there are no changes
Safety & Effectiveness	As safe and effective as, and performs as well as or better than, Optima	Concluded to be as safe and effective and performs as well as or better than the Optima based on in vitro testing.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated. The study involved "in vitro testing", suggesting lab-based experiments rather than patient data.
Data Provenance: The study was conducted as "in vitro testing." No information on country of origin is provided. It is considered retrospective in the sense that it evaluates a modified device against a pre-existing device in a controlled lab environment. No human data was collected.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. The "ground truth" for performance measures like oxygen transfer rate, CO2 transfer rate, pressure drops, etc., is established through direct physical measurements using standardized laboratory methods, not expert interpretation.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. The testing relies on quantifiable physical measurements rather than subjective assessment requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC study was not done. This device is an oxygenator, not a diagnostic imaging device, and does not involve human readers interpreting data or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical medical device (an oxygenator), not an algorithm or AI system. Its performance is inherent to its design and material properties.

7. The type of ground truth used

Type of Ground Truth: The ground truth was based on direct, quantitative physical measurements of various performance characteristics (e.g., oxygen transfer rate, CO2 transfer rate, blood pathway pressure drop, operating volume) obtained through in vitro testing. These measurements were then compared to those of the predicate device.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the conventional sense. The device's design and performance are a result of engineering and manufacturing processes, not data-driven training.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set. The "ground truth" in terms of validating the device's design and manufacturing likely involved engineering specifications, material testing, and internal quality control, rather than data-driven establishment.

Summary

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K.963518

510(k) Pre-Market Notification: Optima XP

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

page 8

1997

9. 510(k) Summary

SUBMITTER:	COBE Cardiovascular, Inc.®14401 W. 65th WayArvada, CO 80004	DEC -
CONTACT PERSON:	Mary L. ArmstrongPhone: (303) 467-6521Fax: (303) 467-6525
DATE PREPARED:	August 27, 1996
DEVICE TRADE NAME:	COBE® Optima XPTM Hollow Fiber Membrane Oxygenator
COMMON NAME:	Hollow Fiber Membrane Oxygenator with Heat Exchanger
CLASSIFICATION NAME:	Cardiopulmonary Bypass Oxygenator and Cardiopulmonary BypassHeat Exchanger
PREDICATE DEVICE:	COBE® Optima TM Hollow Fiber Membrane Oxygenator
DEVICE DESCRIPTION:

The product is sterilized by ethylene oxide gas and has nonpyrogenic fluid pathways.

INDICATIONS FOR USE:

The Optima XP™ is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

TECHNOLOGICAL CHARACTERISTICS:

The Optima XP™ is a new device created by modifying the existing Optima oxygenator by decreasing the fiber diameter and increasing the number of fibers. The result is an increase in membrane surface area in the Optima XP compared to the Optima.

The is no change in the intended use of the device.

There is no change to the heat exchanger. There are no significant changes to the processes or materials used to manufacture or sterilize the device.

Optima XPTM and OptimaTM are trademarks of COBE Laboratories, Inc.

COBE® and COBE Cardiovascular® are registered trademarks of COBE Laboratories, Inc.

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NONCLINICAL TEST RESULTS:

The oxygen transfer rate of the Optima XP is increased compared to the Optima. The new device also has a higher operating volume and gas side pressure drop. Carbon dioxide transfer rate, blood pathway pressure drop, unrecoverable volume, and blood trauma characteristics are not significantly different compared to the Optima.

The heat exchanger in both devices is identical in design, manufacture and installation, and therefore has not been evaluated for this 510(k).

CLINICAL TEST RESULTS:

No clinical testing was performed. Safety and efficacy were determined by in vitro testing.

CONCLUSIONS:

1. The increased membrane surface area of the Optima XP increases the oxygen transfer when compared to the Optima as intended.
1. Corresponding increases in priming volume and gas side pressure drop are acceptable.
1. No statistically significant differences were detected in other performance aspects of the Optima XP when compared to the Optima.
1. In vitro testing demonstrates the Optima XP is as safe and effective and performs as well as or better than the Optima.

Optima XP™ and Optima™ are trademarks of COBE Laboratories, Inc.

COBE® and COBE Cardiovascular® are registered trademarks of COBE Laboratories, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.

Rockville MD 20857

DEC - 8 1997

J. Dennis Bruner, Ph.D. Director of Quality COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, Colorado 80004

Re : K963518 COBE® Optima XP™ Hollow Fiber Membrane Oxygenator Regulatory Class: III (Three) Product Code: DTŽ Dated: November 21, 1997 Nobember 25, 1997 Received:

Dear Dr. Bruner:

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might 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 - J. Dennis Bruner, Ph.D.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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510(k) Pre-Market Notification: Optima XP

Indications For Use

510(k) Number (If known): _ 9 / 35 / 8 / 35 / 8 / 55 / 8

Device Name: COBE® Optima XP TM Hollow Fiber Membrane Oxygenator

Indications For Use:

The Optima XP™ is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lita K. Remacle

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

K 96 3518 510(k) Number

Prescription Use_V (Per 21 CFR 801.109)

Over-The-Counter Use_

Regulation Number and Section

§ 870.4350 Cardiopulmonary bypass oxygenator.

(a)
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.(b)
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.”