The Rapid-Fill Tubeset, manufactured by Baxa Corporation, is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers.

Device Description

The Rapid-Fill Tubeset, is a tubeset used in conjunction with the Rapid-Fill pharmacy pump to fill multiple syringes.

AI/ML Overview

This document describes a 510(k) premarket notification for the Rapid-Fill™ Tubeset, a medical device used for fluid transfer. The submission focuses on demonstrating substantial equivalence to a predicate device, the Exacta-Mix™ 2400 Compounding System Administration Set. The information provided outlines the device's intended use and design, and the testing conducted is primarily focused on safety and manufacturing compliance rather than performance metrics related to diagnostic accuracy or clinical outcomes.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way one would typically expect for a diagnostic or AI-powered device. Instead, the "acceptance criteria" are implied by the nature of a 510(k) submission, which aims to demonstrate substantial equivalence to a legally marketed predicate device. This equivalence is primarily shown through shared features and safety/manufacturing testing.

Acceptance Criteria Category	Specific Criteria (Implied from 510(k))	Reported Device Performance	Comments
Intended Use Equivalence	To transfer fluid from large source containers to smaller containers (pharmac y setting).	The Rapid-Fill™ Tubeset is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into smaller containers.	Matches the predicate device's function, though the direction of transfer (multiple large to one final product vs. one large to multiple small) is noted as a difference but deemed acceptable for equivalence.
Material Equivalence	Non-DEHP Polyvinyl Chloride (PVC) tubing.	Non-DEHP Polyvinyl Chloride (PVC) tubing.	Met. Identical to predicate.
Sterilization Equivalence	Radiation Sterilized fluid path.	Radiation Sterilized fluid path.	Met. Identical to predicate.
Inlet Spike Design Equivalence	Vented and non-Vented source container spike.	Vented and non-Vented source container spike.	Met. Identical to predicate.
Biocompatibility	Meets ISO 10993-1 standards for medical device biocompatibility.	"Biocompatibility testing - ISO 10993-1" is listed as planned/completed testing.	Implied Met. Specific results are not provided, but completion of this testing is crucial for 510(k) clearance.
Packaging Validation	Ensures sterility and integrity of the device until use.	"Packaging validation" is listed as planned/completed testing.	Implied Met. Specific results are not provided.
Sterilization Validation	Ensures the device is sterile according to established standards.	"Sterilization validation" is listed as planned/completed testing.	Implied Met. Specific results are not provided.

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

This information is not applicable and not provided in the document. The testing described (biocompatibility, packaging, sterilization) relates to manufacturing and material safety, not to clinical performance or algorithm evaluation with test sets of patient data.

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 information is not applicable and not provided. The device is an intravascular administration set, not an AI or diagnostic tool that requires ground truth established by experts for performance evaluation.

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

This information is not applicable and not provided.

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 information is not applicable and not provided. The device is an administration set, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. The device is a physical medical device (tubing set), not an algorithm.

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

This information is not applicable and not provided. For this type of device, "ground truth" would refer to established standards for material safety, sterility, and manufacturing quality, verified through laboratory testing rather than clinical expert consensus or pathology on patient data.

8. The sample size for the training set:

This information is not applicable and not provided. The device is not an AI algorithm, so there is no "training set."

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

This information is not applicable and not provided. As there's no training set for an AI algorithm, no ground truth needs to be established in this context.

Summary

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AUG 1 2 2002

510(k) Summary

Submitted by:	Baxa Corporation13760 E. Arapahoe RoadEnglewood, CO 80112
Contact Person:	Karl Steineck
Phone:	303-617-2181
Fax:	303-690-4804
Date Prepared:	July 26, 2001
Manufacturing Facility:	Baxa Corporation13760 E. Arapahoe RoadEnglewood, CO 80112
Submitted Device:	Trade Name:	Rapid-Fill™ Tubeset(s)
	Common Name:	Administration Set
Device Classification:	Class II21 CFR § 880.5440 Intarvascular administration set
	(a) Identification. An intravascular administration set is a deviceused to administer fluids from a container to a patient's vascularsystem through a needle or catheter inserted into a vein. Thedevice may include the needle or catheter, tubing, a flow regulator,a drip chamber, an infusion line filter, an I.V. set stopcock, fluiddelivery tubing, connectors between parts of the set, a side tubewith a cap to serve as an injection site, and a hollow spike topenetrate and connect the tubing to an I.V. bag or other infusionfluid container.(b) Classification. Class II (performance standards)
Predicate Device:	Exacta-Mix™ 2400 Compounding System Administration Set510(k): K002705, Cleared March 28, 2001Baxa CorporationEnglewood, CO
Product Description:	The Rapid-Fill Tubeset, is a tubeset used in conjunction with theRapid-Fill pharmacy pump to fill multiple syringes.
Intended Use:	The Rapid-Fill Tubeset, is a fluid transfer device used in thepharmacy to provide the fluid path for transferring large sourcecontainer ingredients into a smaller containers.

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Statement of substantial equivalence-

The Rapid-Fill Tubeset is very similar to the Exacta-Mix 2400 Compounding System Administration set in the following areas; intended use, operation, and function. The Rapid-Fill Tubeset and the predicate device are both used to transfer large source into smaller containers.

A summary of the essential features between the Exacta-Mix 2400 Compounding System Administration set (predicate device) and the Rapid-Fill Tubeset is contained in Table 1

Table 1

Comparison between the Exacta-Mix™ 2400 Compounding System Administration Set and the new device, Rapid-Fill tubeset.

Feature	Exacta-Mix AdministrationSet(Predicate Device)	Rapid-Fill™ Tubeset
Intended use	used to transfer multiple largecontainer ingredients into onefinal solution	Used to transfer one largecontainer ingredient tomultiple small containers.
Inlet Spike	Vented and non-Vented sourcecontainer spike	Vented and non-Ventedsource container spike
Tubing	Non- DEHP PolyvinylChloride (PVC)	Non- DEHP PolyvinylChloride (PVC)
Sterile Fluid Path	Radiation Sterilized	Radiation Sterilized

From Table 1 it can be seen that the two types of devices share the same basic features for fluid transfer.

Testing:

Testing will include: Biocompatibility testing - ISO 10993-1 Packaging validation Sterilization validation

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top and left side of the profile graphic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2002

Mr. Karl Steinbeck Baxa Corporation 13760 East Arapahoe Road Englewood. California 80112

Re: K022523

Trade/Device Name: Rapid-Fill Tubeset, Model 90005 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: July 19, 2002 Received: July 30, 2002

Dear Mr. Steinbeck:

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 vour 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 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

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Page 2 - Mr. Steinbeck

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) 594-4618. 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Timothy A. Ulatowski

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

Enclosure

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SECTION I: PRE-MARKET SUBMISSION (CONTINUED)

Indications for Use Statement (New and Predicate Device)

. .

New Device

・・.

Applicant:	Baxa Corporation
510(k) Number (if known)
New Device Name:	Rapid-Fill™ Tubeset
Indications For Use:	The Rapid-Fill Tubeset, manufactured by Baxa Corporation, is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers.

Patricia Curenite
(Division Sign. O.R.)

(Division Sign-Off) Division of Anesthesiology, Gener Infection Control, Dental Devices

510(k) Number: K022523

000011

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.