Micro Prime Delivery Lines minimize the blood prime volume in the extracorporeal circuit. For pediatric cardiopulmonary bypass, where excessive priming volume can increase surgical risk, Micro Prime delivery lines offer a distinct advantage. Micro Prime Delivery Lines consist of a dual lumen extrusion: a round "blood" lumen used to convey blood to/from the patient, and a crescent shaped "occlusion" lumen which surrounds the blood lumen, and is used to purge excess prime volume from the blood lumen.

In use, both lumens are initially primed with saline. Once the tubing has been primed, the occlusion lumen is pressurized with additional saline, collapsing the blood lumen and purging excess priming fluid from the blood lumen. Releasing the pressure from the occlusion lumen causes the blood lumen to re-open to its normal shape. In this manner, Micro Prime Delivery Lines regligible blood volume to prime as compared to conventional delivery lines.

AI/ML Overview

The provided text describes a 510(k) summary for the Micro Prime Delivery Lines, a medical device. The summary outlines the device's description, indications for use, and a summary of testing conducted to demonstrate its safety and effectiveness. However, it does not explicitly state "acceptance criteria" in a tabulated format or provide a detailed study report that directly maps device performance against predefined criteria in a way that allows for a direct comparison with specific quantitative thresholds.

Instead, the document describes the types of tests performed and the nature of their conclusions, indicating that the device met functional requirements and performed comparably or better than predicate devices.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not provide a formal table of acceptance criteria with numerical targets. Instead, it describes general successful outcomes and comparability to predicate devices. The "reported device performance" is descriptive rather than quantitative for specific criteria in many instances.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Requirements (Post-sterilization, aging, & ship test)	"Units passed functional requirements." "Positive pressure experiments (arterial and cardioplegia) met all acceptance criteria and are qualified for 2c ETO and one-year shelf life."
Biocompatibility	"Biocompatibility testing and reference to Device Master File for silicone rubber extrusion demonstrate suitability of the materials."
Blood Trauma	"Statistical analysis of the data using hypothesis test of means indicates that blood trauma associated with Micro Prime Delivery Tubes is comparable to blood trauma for conventional delivery tubes." (Measured via plasma hemoglobin, white blood cell count, and platelet count.)
Pressure Drop in Extracorporeal Circuit	"Analysis of this data indicates that pressure drop in Micro Prime Delivery Tubes is nominally lower than conventional delivery tubes."
Effect of Sterilization/Aging on Performance	"Comparison of sterile/aged, non-sterile-non aged product revealed there is no statistically significant difference between groups."
Package Integrity	"Package Integrity Ship Testing for one year aging showed no changes to the specimens and that the package held integrity under the conditions tested."
Overall Safety	"Testing confirmed that the design did not introduce any new safety concerns and performed equivalent to or better than conventional PVC cardiopulmonary bypass lines." Note: "Due to the results from venous drainage experiments, the Micro Prime Delivery Line is contraindicated for venous drainage." This indicates an identified limitation and appropriate action to update the indications for use/warnings rather than a failure of all safety criteria universally.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Blood Trauma/Pressure Drop Test: "five 3/16" ID Micro Prime delivery tubes and five 3/16" ID conventional extracorporeal delivery tubes"
Data Provenance: Not explicitly stated (e.g., country of origin). The description of the tests ("conducted functional testing," "assessed over a 6-hour period using bovine blood") suggests these were prospective bench tests or in-vitro tests rather than human clinical data. The use of "bovine blood" explicitly indicates an animal-derived sample for the blood trauma study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the studies described are primarily functional, mechanical, and biocompatibility bench/in-vitro tests rather than studies requiring expert interpretation (e.g., image analysis, clinical diagnosis). The "ground truth" for these tests would be objective measurements (e.g., plasma hemoglobin levels, pressure readings, visual inspection for package integrity).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the type of bench and in-vitro testing described, which relies on objective measurements rather than human reader adjudication of subjective interpretations.

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

This section is not applicable. The device is a physical medical tubing product, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.

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

This section is not applicable, as the device is a physical tubing product and not a software or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the various tests described was based on:

Functional measurements: Objective measurements of device performance (e.g., successful purging of prime volume, pressure readings, mechanical integrity).
Biocompatibility standards: Reference to Device Master File for silicone and established biocompatibility testing protocols.
Laboratory assays: For blood trauma, objective measurement of plasma hemoglobin, white blood cell count, and platelet count in bovine blood.
Physical inspection: For package integrity.
Statistical comparison: Performance compared to conventional/predicate devices using statistical hypothesis testing.

8. The sample size for the training set

This section is not applicable. The provided text describes studies for a physical medical device, not a machine learning or AI algorithm that requires a "training set."

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

This section is not applicable, as there is no training set for this type of device.

Summary

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K04/650

510(k) Summary

Submitted on behalf of:

Company Name:	InnovX Medical, Inc.
Address:	16631 78th Avenue North
	Maple Grove, MN 55311
	Telephone: 763-442-1384

by:

by:	Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082
Telephone:	715-549-6035
Fax:	715-549-5380
CONTACT PERSON:	Elaine Duncan
DATE PREPARED:	June 9, 2004

TRADE NAME:	Micro Prime Delivery Lines
COMMON NAME:	Arterial and cardioplegia delivery tubing

SUBSTANTIALLY EQUIVALENT TO:

Micro Prime is substantially equivalent to conventional cardiopulmonary blood and cardioplegia lines with the difference of reduced priming volume. Silicone materials used to produce this unique design are biocompatible. Silicone cardiopulmonary bypass components have been used safely for more than two decades (K843444.) Predicate product, such as the Medtronic One Piece Pediatric Cannula are focused to the pediatric patient's special needs (K024069) Standard tubing sets (arterial and cardioplegia) from PVC are well recognized in the predicate device literature (K803277 predicate use of Tygon PVC tubing, and K964205, Better-Tubing TM)

Micro Prime Delivery Lines minimize the blood prime volume DESCRIPTION of the DEVICE: in the extracorporeal circuit. For pediatric cardiopulmonary bypass, where excessive priming volume can increase surgical risk, Micro Prime delivery lines offer a distinct advantage. Micro Prime Delivery Lines consist of a dual lumen extrusion: a round "blood" lumen used to convey blood to/from the patient, and a crescent shaped "occlusion" lumen which surrounds the blood lumen, and is used to purge excess prime volume from the blood lumen.

INDICATIONS FOR USE:

Micro Prime Delivery Lines are indicated for use to convey arterial blood and cardioplegia with minimal prime volume in the extracorporeal circuit.

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510(k) Summary-Continued

SUMMARY of TESTING:

InnovX Medical, Inc. conducted functional testing for Micro Prime delivery line samples, which had been ethylene oxide sterilized twice, aged for the equivalent of one year, and ship tested at cold and at warm temperatures. Units passed functional requirements.

Biocompatibility testing and reference to Device Master File for silicone rubber extrusion demonstrate suitability of the materials.

The potential for blood trauma was assessed over a 6-hour period using bovine blood in five 3/16" ID Micro Prime delivery tubes and five 3/16" ID conventional extracorporeal delivery tubes, flowing through a simulated extracorporeal circuit. Blood trauma was assessed by measuring plasma hemoglobin, white blood cell count, and platelet count at half hour intervals over the duration of the test. Statistical analysis of the data using hypothesis test of means indicates that blood trauma associated with Micro Prime Delivery Tubes is comparable to blood trauma for conventional delivery tubes.

Pressure drop data was simultaneously monitored across the ten samples in the blood trauma evaluation to assess whether Micro Prime Delivery Tubes had a negative impact on pressure in the extracorporeal circuit. Analysis of this data indicates that pressure drop in Micro Prime Delivery Tubes is nominally lower than conventional delivery tubes.

Comparison of sterile/aged, non-sterile-non aged product revealed there is no statistically significant difference between groups. Package Integrity Ship Testing for one year aging showed no changes to the specimens and that the package held integrity under the conditions tested. Design Verification was conducted to assure product met criteria. Positive pressure experial and cardioplegia) met all acceptance criteria and are qualified for 2c ETO and one-year shelf life. Due to the results from venous drainage experiments, the Micro Prime Delivery Line is contraindicated for venous drainage.

Testing confirmed that the design did not introduce any new safety concerns and performed equivalent to or better than conventional PVC cardiopulmonary bypass lines.

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Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a symbol that looks like three stylized human profiles facing to the right. The profiles are stacked on top of each other and are connected by a wavy line at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2004

InnovX Medical, Inc. c/o Elaine Duncan 16631 78th Avenue North Maple Grove, MN 55311

Re: K041650

Micro Prime Delivery Lines Regulation Number: 870.4210 Regulation Name: Vascular Catheter, Cannula, or Tubing Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: 74 DWF Dated: June 15, 2004 Received: June 17, 2004

Dear Ms. Duncan:

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 conniner or prof to 1125 2011 , 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.

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

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Page 2 - Ms. Elaine Duncan

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 (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. 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), 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,

Donna R. Kirchner

Bram D. Zuckerman, M.D. CD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known). K41650
Device Name: Micro Prime Delivery Lines

Indications For Use:

Micro Prime Delivery Lines are indicated for use to convey arterial blood and cardioplegia with minimal prime volume in the extracorporeal circuit.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Lachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K041650

Page 1 of

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
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.(b)
Classification. Class II (performance standards).