Genesis BPS FLU-ADMIN I.V. Sets are intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter into a vein.

Device Description

The tubing assembly consists of spike and drip chamber connected to tubing with a "Y" injection site and a male luer slip. Between the tubing with a "Y" injection site and a male luer slip is a roller clamp. These sets deliver 20 drops/ml, with the exception of set model 0151C which delivers 60 drops/ml. All models ending with a "C" have a check valve. All sets are vented with the exception of model 0160, which is non-vented.

AI/ML Overview

The provided document is a 510(k) summary for FLU-ADMIN I.V. SETS, which are medical devices used for administering fluids. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing devices and proving that it performs similarly.

It does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria in the manner typically reported for AI/Machine Learning devices. The document primarily addresses the administrative and regulatory aspects of bringing the device to market, including:

Applicant and Contact Information: Basic details about Genesis BPS, LLC.
Device Information: Trade name, common/usual name, classification, and product codes.
Predicate Device: Identification of previously cleared devices to which the FLU-ADMIN I.V. SETS are being compared (K11914 FLU VEN I.V. SETS and K843692 FLU VEN I.V. SET 0153-C).
Device Description: A physical description of the tubing assembly components.
Intended Use: The purpose of the device (administering fluids from a container to a patient's vascular system).
FDA Correspondence: The FDA's letter granting substantial equivalence, which is a regulatory approval based on the comparison to predicate devices, not on a new clinical study with acceptance criteria for device performance.

Therefore, the requested information components related to acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies for specific performance metrics cannot be extracted from this document because it is a regulatory submission for substantial equivalence rather than a detailed performance study report.

The "acceptance criteria" for this type of submission are typically that the new device has the same intended use and technological characteristics as the predicate device, or that any differences do not raise new questions of safety and effectiveness. The "study" proving this is the 510(k) submission itself, which primarily relies on comparison and compliance with general controls, rather than a novel performance study against predefined numerical targets.

Summary

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tos2027

Genesis BPS, LLC 510(k) Notification FLU-ADMIN I.V. SETS

July 15, 2008

Page 4

510(k) Summary

FEB 1 3 2009

Applicant:

Address

Genesis BPS, LLC 65 Commerce Way Hackensack, NJ 07601

Contact Person:

Address Telephone Fax Email

Jerrold B. Grossman, Ph.D. President, Genesis BPS, LLC 65 Commerce Way Hackensack, NJ 07601 (201) 708-1400 (201) 708-1104 jgrossman@genesisbps.com

Submission Correspondent: Telephone Fax Email

Classification Name:

Registration-Number !-

Product code:

Class:

Carolyn Amditis, BSMT (ASCP) (201) 708-1400 (201) 708-1104 camditis@genesisbps.com

Device Information: Trade Name:

These devices will be marketed under the trade name FLU-ADMIN I.V. SETS

Common/Usual Name: Intravascular Administration Set

Set, Intravascular Administration (21 CFR 880.5440)

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Predicate Device:

Establishment

Device Description:

Intended Use:

FLU VEN I.V. SETS (K11914) FLU VEN I.V. SET 0153-C (K843692)

Intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

FEB 1 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Genesis BPS, LLC Ms. Carolyn Amditis, BSMT (ASCP) Manager, Technical Services & Quality Control 65 Commerce Way Hackensack, New Jersey 07601

K082027 Re:

Trade/Device Name: FLU-ADMIN I.V. Sets Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 28, 2009 Received: February 2, 2009

Dear Ms. Amditis:

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.

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Page 2 - Ms. Amditis

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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours; --

Antony D. Auster for

Ginette Y. Michaud, M.D Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Genesis BPS, LLC 510(k) Notification FLU-ADMIN I.V. SETS AMENDMENT

Indications for Use Statement

510(k):

Device Name: FLU-ADMIN I.V. Sets

Indications of Use: Genesis BPS FLU-ADMIN I.V. Sets are intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter into a vein.

Prescription Use	XX and/or Over-the-Counter Use
(Part 21 CFR 801 Subpart D)	(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number:	K082027

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.