A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.

Device Description

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Blood Hand Pump Set) and is not a study. Therefore, it does not contain detailed information about acceptance criteria, specific performance metrics, sample sizes, or ground truth establishment typically found in a scientific study.

The document indicates that the device's substantial equivalence was determined based on its "technological characteristics" and "performance data" indicating it "meets specified requirements." However, it does not specify what those requirements are or how the performance data was generated beyond a general statement.

Here's an analysis based on the information available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicit. The document states "The performance data indicate that the Cardinal Health, Alaris Products Blood Hand Pump Set meets specified requirements."	The device is "substantially equivalent" to predicate devices (K882302, K881321) regarding technological characteristics and performance. The flow rate for hand pump compression administration "may be as much as twice that of gravity flow." (This is a characteristic, not a performance metric against a specific criterion).

Missing Information:

Specific quantitative acceptance criteria (e.g., minimum flow rate, pressure limits, material biocompatibility, sterility) are not provided.
Actual measured performance values against these criteria are not given.

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

Missing Information:

Sample Size: Not reported. The document does not describe any specific "test set" of data or how it was generated.
Data Provenance: Not reported. It's unclear if any testing involved human subjects or was entirely bench testing, and if so, where it took place (country of origin). The document refers to "performance data" generally.
Retrospective/Prospective: Not specified.

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

Missing Information:

Not applicable. This type of device (blood administration set) does not typically involve "ground truth" derived from expert image interpretation or clinical diagnosis in the way an AI diagnostic device would. Its performance is assessed through engineering and biocompatibility testing. The "ground truth" for a device like this would be engineering specifications and safety standards.

4. Adjudication Method for the Test Set

Missing Information:

Not applicable for this type of device and submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Missing Information:

Not applicable. This is a medical device for fluid administration, not an AI-assisted diagnostic tool for human readers. No human interpretation is involved.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Missing Information:

Not applicable. This is not an AI algorithm. Its performance is inherent to its mechanical design and materials.

7. Type of Ground Truth Used

Missing Information:

The document implies that the ground truth/basis for evaluation was adherence to engineering specifications, safety standards, and equivalence to predicate devices. It does not mention pathology, outcomes data, or expert consensus in a clinical sense for performance evaluation.

8. Sample Size for the Training Set

Missing Information:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Missing Information:

Not applicable. This device is not an AI/ML algorithm that requires a training set and associated ground truth.

In summary: The provided 510(k) summary is a regulatory document demonstrating substantial equivalence, not a detailed scientific study. It focuses on comparing the new device's technological characteristics and overall performance to already cleared predicate devices rather than presenting detailed raw data, specific acceptance criteria values, sample sizes, or methodologies of internal validation tests. For medical devices like this, performance data typically refers to results from bench testing (e.g., flow rate tests, pressure resistance, sterility testing, material compatibility) and not clinical trial data involving "ground truth" from experts for diagnostic purposes.

Summary

{0}------------------------------------------------

KD50115

APR - 1 2005 SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products Blood Hand Pump Set

SUBMITTER INFORMATION

A.	Company Name:	Cardinal Health, Alaris® Products
B.	Company Address:	10221 Wateridge CircleSan Diego, CA 92121-2733
C.	Company Phone:Company Fax:	(858) 458-7830(858) 458-6114
D.	Contact Person:	Stacy L. LewisSr. Regulatory Affairs SpecialistCardinal Health, Alaris Products
E.	Date Summary Prepared:	March 16, 2005

DEVICE IDENTIFICATION

A.	Generic Device Name:	Blood Administration Set
B.	Trade/Proprietary Name:	Blood Hand Pump Set
C.	Classification:	Class II
D.	Product Code:	BRZ, Blood Transfusion Set

DEVICE DESCRIPTION

The Blood Hand Pump Administration Set is a single use, disposable, gravity blood set with a blood filter and hand pressure pump. The addition of the hand pressure pump provides the capability for delivering blood/blood products more rapidly by compressing the pump by hand. Blood sets with hand pressure pumps are typically used by healthcare professionals in clinical settings, including emergency rooms, intensive care units, operating rooms, surgery centers, trauma centers, and pre-hospital transport. Using a hand pump set increases the flow rate and helps ensure timely delivery.

{1}------------------------------------------------

SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products Blood Hand Pump Set Page 2 of 2

SUBSTANTIAL EQUIVALENCE

The Cardinal Health, Alaris Products Blood Hand Pump Administration Set is of comparable type and is substantially equivalent to the following predicate devices:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
ALARIS BloodAdministration Set	Cardinal Health, AlarisProducts	K882302	7/12/1988
Baxter Fenwal Y-TypeBlood/Solution Set	Baxter Corporation	K881321	6/16/1998

INTENDED USE

The Blood Hand Pump Set will be used for patients that require blood. The set can be used by gravity flow or with hand pump compressions, depending on how quickly blood delivery is needed. It is intended for use by healthcare professionals (including nurses, doctors, emergency technicians, etc.) in clinical environments. The flow rate for hand pump compression administration may be as much as twice that of gravity flow.

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Cardinal Health, Alaris Products Blood Hand Pump Set and the predicate devices has been performed. The results of this comparison demonstrate that the Blood Hand Pump Set is equivalent to the marketed predicate devices in technological characteristics.

PERFORMANCE DATA

The performance data indicate that the Cardinal Health, Alaris Products Blood Hand Pump Set meets specified requirements and is substantially equivalent to the predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three curved lines that resemble an abstract representation of a human form or a symbol related to health and well-being.

Public Health Service

APR - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist Cardinal Health, Alaris Products 10221 Wateridge Circle San Diego, California 92121-2772

Re: K050115

Trade/Device Name: Blood Hand Pump Administration Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: BRZ Dated: January 17, 2005 Received: January 18, 2005

Dear Ms. Lewis:

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 (1 will) in the 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.

{3}------------------------------------------------

Page 2 - Ms. Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisor and a determination that your device complies with other requirements mount that I Dr mas and regulations administered by other Federal agencies. or the recor any a vary a vat's requirements, including, but not limited to: registration r od into comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF Partis of 1, 2017, 1977, 1991, 1991, 1991, 1991, 1997, 1991, 1991, 1991, 11 requirements as bet form in one of 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) This letter wifi une in J . 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), rr you donto the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj oveans 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/industry/support/index.html.

Sincerely vours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number:	K050115	(To Be Assigned By FDA)
Device Trade Name:	Blood Hand Pump Administration Set

Indications For Use:

A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.

Prescription Use _________X

(Per 21 CFR 801.109)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cim
200

்லா இறந-Off) . Ton of Anesthesiology, General Hospital, . Josion Control, Dental Devices

Number: koso115

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.