The Pinnacle™ TPN Management System Transfer Set is intended to be used with the Pinnacle TPN Management System gravimetric pharmacy compounding device in the pharmacy to provide a sterile fluid path for the compounding of ingredients from multiple source containers into a final container.

Device Description

The Pinnacle™ TPN Management System Transfer Set is available in a 6-lead or a 9- lead configuration with vented or non-vented spikes. The detachable lipid line may be used when compounding lipid formulations into a dual-chambered final container.

AI/ML Overview

The provided text describes a medical device, the Pinnacle™ TPN Management System Transfer Set, and its 510(k) submission for regulatory clearance. However, the document does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting detailed performance studies with acceptance criteria as typically found in clinical trials or dedicated performance validation reports. The FDA's letter states that they have "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is based on the device being "similar in intended use, operation and function" to the identified predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text, as this information is not present.

Here's a breakdown of why the requested information is absent and what types of information are provided:

Acceptance Criteria & Reported Performance: Not present. The document focuses on showing similarity to predicate devices rather than independent performance against predefined criteria.
Study Details: There is no description of a study designed to statistically prove performance against acceptance criteria. The 510(k) process primarily relies on demonstrating substantial equivalence, which often involves testing to ensure the new device functions similarly to the predicate, rather than a standalone clinical or performance study establishing new efficacy or safety thresholds.
Sample Size (Test Set), Data Provenance, Experts, Adjudication, MRMC, Standalone Study, Ground Truth Type, Training Set Size, Training Set Ground Truth: All of these details are typically associated with performance studies, especially for AI/ML devices or diagnostics where quantifiable metrics like sensitivity, specificity, or accuracy are established. Since no such performance study is detailed in this 510(k) summary, these points cannot be addressed.

The document primarily provides:

Submitter and Device Information: Name, contact, device name, classification.
Intended Use: The purpose of the device.
Predicate Devices: Identification of existing devices to which the new device is compared for substantial equivalence.
Description: Physical characteristics and configurations of the transfer set.
FDA Communication: The FDA's letter confirming substantial equivalence and providing regulatory guidance.

To find the type of information you are requesting, one would typically look for a dedicated performance study report or clinical trial documentation, which is not part of this 510(k) summary.

Summary

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Pinnacle™ TPN Management System Transfer Set

K041222
1 of 2

OCT 1 4 2004

7.0 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 5 807.92."

SUBMITTER:	B. Braun Medical Inc.1601 Wallace Drive, Ste 150Carrollton, TX 75006-6690(972) 245.2243Contact: Linda Morgan, RN, Senior RegulatoryAffairs Specialist
DEVICE NAME:	Pinnacle™ TPN Management System Transfer Set
COMMON OR USUALNAME:	I.V. Fluid Transfer Set
DEVICECLASSIFICATION:	Class II per Code of Federal Regulations,Title 21, § 880.5440, Intravascular AdministrationSets, product code LHI and NEP
PREDICATE DEVICES:	Baxa CorporationExacta-Mix™ 2400 Compounding SystemAdministration Set,K002705Baxter Healthcare CorporationAutomix® 3+3/AS Compounder TransferSet,K961008
DESCRIPTION:	The Pinnacle™ TPN Management System TransferSet is available in a 6-lead or a 9- lead configurationwith vented or non-vented spikes. The detachablelipid line may be used when compounding lipidformulations into a dual-chambered final container.

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Pinnacle™ TPN Management System Transfer Set

INTENDED USE:

The Pinnacle™ TPN Management System Transfer Set is to be used with the Pinnacle TPN Management System, a gravimetric pharmacy compounding device.

SUBSTANTIAL EQUIVALENCE:

The Pinnacle™ TPN Management System Transfer Set is similar in intended use, operation and function to Exacta-Mix 2400 Compounding System Administration Set, distributed by Baxa Corporation, K002705, and the Automix 3+3/AS Compounder Transfer Set, distributed by Baxter Healthcare corporation, K961008.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle, represented by three curved lines that suggest the bird's head, body, and tail feathers.

Public Health Service

OCT 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Linda Morgan, RN Sr. Regulatory Affairs Specialist B. Braun Medical. Incorporated 1601 Wallace Drive, Suite 150 Carrollton, Texas 75006-6690

Re: K041222

Trade/Device Name: Pinnacle™ TPN Management System Transfer Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: August 26, 2004 Received: August 27, 2004

Dear Ms. Morgan:

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. Morgan

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 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 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,

Susan Rumm
Chiu Lin, Ph.D.

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

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Pinnacle™ TPN Management System Transfer Set

Indications for Use Statement 2.0

Page _________________________________________________________________________________________________________________________________________________________________________

1641222

। दर्द

510(k) Number (if known): _K041222

Pinnacle™ TPN Management System Transfer Set Device Name:

Indications For Use:

The Pinnacle Transfer Set is intended to be used with the Pinnacle TPN Management System gravimetric pharmacy compounding device in the pharmacy to provide a sterile fluid path for the compounding of ingredients from multiple source containers into a final container.

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)

Antony 29me

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.