The SAFE MAXI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and to defoam and filter intra-thoracic suction blood prior to returning it to the extracorporeal circuit.

Device Description

SAFE MAXI venous/cardiotomy reservoir is a hard shell reservoir with separate venous and cardiotomy inlets. The venous inlet with 175 micron venous filter is placed at the bottom of the reservoir, which provides a bottom to top venous blood flow. Returning suction blood enters the large surface area 20 micron depth filter at the top of the reservoir. The SAFE MAXI venous/cardiotomy reservoir is single-use, disposable, sterile and non-pyrogenic. The reservoir is a sealed type for vacuum applications. The maximum capacity of the reservoir is 4000 ml.

AI/ML Overview

This 510(k) summary describes a medical device, the SAFE MAXI venous/cardiotomy reservoir, and its claim of substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving the device meets them through a dedicated study with defined metrics. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted directly from this document.

However, based on the provided text, here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating similar characteristics and comparable performance to predicate devices to establish substantial equivalence.

Characteristic / Performance Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Biocompatible and non-toxic	Determined to be biocompatible and nontoxic, based on testing of the predicate SAFE MINI reservoir due to similar design and material content.
Blood Cell Damage	Comparable to predicate device	Performed using the same blood pool as the Gish Biomedical reservoir, implying comparable performance. (Specific metrics of "damage" are not provided).
Effectiveness/Operational Characteristics	Functional as intended	Function determined by evaluating operational characteristics. (Specific metrics are not provided).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of a clinical or performance study with a defined sample size. The evaluation appears to be based on:

Biocompatibility: Likely laboratory testing, potentially on material samples or the predicate device.
Blood Cell Damage Test: This was performed using a "same blood pool" setup, suggesting a comparative in vitro or ex vivo experiment. The number of samples or runs is not specified.
Effectiveness Testing: "Evaluating its operational characteristics" suggests various engineering or bench tests.

Data Provenance: Not explicitly stated, but given the manufacturer (POLYSTAN A/S, Denmark), the testing would likely have taken place in a laboratory setting, possibly in Denmark or the US. The nature of these tests (e.g., in vitro, bench testing) means they are not "retrospective" or "prospective" in the clinical trial sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This type of device evaluation (substantial equivalence to predicates for a physical component) does not involve expert consensus on "ground truth" derived from clinical cases, as would be common for diagnostic algorithms or imaging devices.

4. Adjudication Method for the Test Set

Not applicable. As above, this isn't a study design that involves expert adjudication of findings.

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

Not applicable. This device is a passive medical component (blood reservoir) and does not involve AI or human "readers."

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

Not applicable. This device is a physical component, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the established performance and safety of the predicate devices. The device's substantial equivalence is established by demonstrating (through laboratory/bench testing) that its performance and safety characteristics are comparable.

Biocompatibility: Chemical and biological testing standards (e.g., ISO 10993).
Blood Cell Damage: Measured parameters (e.g., free hemoglobin, platelet activation) in an in vitro setup.
Effectiveness: Engineering performance metrics (e.g., flow rates, defoaming efficiency, filtration efficacy, volume capacity).

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device submission.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

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Y02251/

AUG 0 6 2002

Summary of Safety and Effectiveness 4

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for SAFE MAXI venous/cardiotomy reservoir as required by section 807.92(c).

Submitter's Information:

Name: Address: Phone: Fax Contact person: Date of preparation: POLYSTAN A/S Walgerholm 8, 3500 Værløse, Denmark + 45 44 65 15 66 + 45 44 68 15 66 Dana Olsen, Requlatory Affairs July 10, 2002

Device name:

SAFE MAXI venous/cardiotomy reservoir Trade Name: Common/Usual name: blood reservoir Cardiopulmonary bypass blood reservoir Classification name: (21 CFR - 870.4400) Cardiopulmonary bypass defoamer (21 CFR - 870.4230)

Cardiopulmonary bypass cardiotomy suction line blood filter (21 CFR- 870.4270)

Predicate Device Name(s):

SAFE MINI oxygenator with venous/cardiotomy reservoir - 510(k) no. K980974 Gish Biomedical Cardiotomy/Venous Reservoir 510 (k) no. K883923

Device Description:

The SAFE MAXI venous/cardiotomy reservoir is single-use, disposable, sterile and non-pyrogenic. The reservoir is a sealed type for vacuum applications. The maximum capacity of the reservoir is 4000 ml.

Intended Use:

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Technological Characteristics Summary:

Biocompatibility and Blood Cell Damage Testing: o
The SAFE MAXI venous/cardiotomy reservoir has similar design characteristics and material content as the SAFE MINI reservoir K980974 except that the reservoirs differ in size. Based on the biocompatibility testing performed on the SAFE MINI (the predicate device), the SAFE MAXI was determined to be biocompatible and nontoxic, therefore, safe for its intended use.

Blood cell damage test of the SAFE MAXI reservoir and the Gish Biomedical reservoir were performed using the same blood pool.

Effectiveness Testing: o
The function of the SAFE MAXI reservoir was determined by evaluating its operational characteristics.

Conclusion:

The biocompatibility, performance, and function test data demonstrated that the SAFE MAXI reservoir is substantially equivalent to the predicate devices SAFE MINI reservoir (K980974) and Gish Biomedical Cardiotomy/Venous Reservoir (K883923).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 6 2002

Polystan A/S c/o Ms. Dana Olsen Regulatory Affairs 8, Walgerholm DK-3500 Vaerlose DENMARK

Re: K022281

Trade Name: SAFE MAXI Venous/Cardiotomy Reservoir Regulation Number: 21 CFR 870.4400, 870.4230, and 870.4270 Regulation Name: Cardiopulmonary Bypass Blood Reservoir/Defoamer and Suction Line Blood Filter Regulatory Class: Class II (two) Product Code: DTN Dated: July 10, 2002 Received: July 15, 2002

Dear Ms. Olsen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Dana Olsen

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); 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. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dark Telle

Donna-Bea Tillman, Ph.D." Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use 3

Statement of Indication for Use

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature
Division of Cardiovascular & Respiratory Devices

510(k) Number	K022281
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Prescription Use	X	OR	Over-The-Counter Use
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Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.