(157 days)
Not Found
No
The document describes a transfer set for a gravimetric compounding system, which is a physical component for fluid transfer. There is no mention of software, algorithms, or any technology related to AI or ML.
No
This device is a transfer set used in a pharmacy for compounding ingredients, not for directly treating a patient.
No.
The device is a transfer set for a pharmacy compounding system used to prepare total parenteral nutrition (TPN) solutions. It is involved in the compounding process, not in diagnosing medical conditions.
No
The device description clearly states it is a "Transfer Set" available in different lead configurations with spikes, indicating it is a physical, hardware component used with a compounding device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for compounding ingredients from multiple source containers into a final container in a pharmacy setting. This is a process related to preparing medications, not performing diagnostic tests on biological samples.
- Device Description: The description details a transfer set with leads and spikes, designed for fluid transfer during compounding. This aligns with a medical device used in a pharmacy for preparation, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the Pinnacle™ TPN Management System Transfer Set is a medical device used in a pharmacy for compounding, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pinnacle™ TPN Management System Transfer Set is to be used with the Pinnacle TPN Management System, a gravimetric pharmacy compounding device.
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.
Product codes
LHI, NEP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 150
Carrollton, TX 75006-6690
(972) 245.2243
Contact: Linda Morgan, RN, Senior Regulatory
Affairs Specialist |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Pinnacle™ TPN Management System Transfer Set |
| COMMON OR USUAL
NAME: | I.V. Fluid Transfer Set |
| DEVICE
CLASSIFICATION: | Class II per Code of Federal Regulations,
Title 21, § 880.5440, Intravascular Administration
Sets, product code LHI and NEP |
| PREDICATE DEVICES: | Baxa Corporation
Exacta-Mix™ 2400 Compounding System
Administration Set,
K002705
Baxter Healthcare Corporation
Automix® 3+3/AS Compounder Transfer
Set,
K961008 |
| 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. |
1
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.
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.
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.
2
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.
3
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
4
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)
OR
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 ________________________________________________________________________________________________________________________________________________________________