(391 days)
Not Found
No
The 510(k) summary describes a standard blood transfusion set and makes no mention of AI or ML technology. The performance testing is based on established standards for such devices.
No.
The device administers blood, it does not treat a disease or condition.
No
The device description states it is used "to administer Blood to a patient's vascular system," which is a treatment or delivery function, not a diagnostic one.
No
The device description clearly states it is a physical device ("Single Use, Non-toxic, Sterile, Non-Pyrogenic devices used to administer Blood... through a Needle or Catheter") and the performance studies focus on physical properties and standards (ISO 1135-4, biocompatibility, sterility). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer blood and blood derivatives to a patient's vascular system. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description focuses on the physical components and function of a set used for transfusion, not for analyzing samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) outside the body to provide information about a patient's health status, disease, or condition.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is used to deliver a substance into the body.
N/A
Intended Use / Indications for Use
To administer Blood and Blood Derivatives into a patient's vascular system
Product codes (comma separated list FDA assigned to the subject device)
BRZ
Device Description
The PENTATRASFU™ Blood Transfusion Sets are Single Use, Non-toxic, Sterile, Non-Pyrogenic devices used to administer Blood to a patient's vascular system through a Needle or Catheter inserted into a vein.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The PENTATRASFU™ blood Transfusion Sets have been subjected to performance and safety testing to verify mechanical properties and functioning, as well as biocompatibility and sterility, using FDA recognized Standards, where applicable. These Blood Transfusion Sets have been tested for performance as per recognized Standard Guidance Document ISO 1135-4 Second Edition 1998-03-15 Transfusion Equipment for Medical Use - Part 4 Transfusion Sets for Single Use (General Plastic Surgery/Gen. Hospital), which is the same standard that applies to the Predicative devices. The results of the Performance Testing showed that these Blood Transfusion Sets met the testing requirements as described on the ISO 1135-4 Recognized Guidance Document. Biocompatibility testing conforms to FDA recognized standard 10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Tuta Healthcare Blood/Solution Administration Sets (K023039), Baxter Healthcare Blood Transfusion Set (K924721)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Number: K041496
510(k) SUMMARY
(As Required by 21 CFR 807. 92)
.
11 - 11 - 11 - 11 -
JUN 3 0 2005
| Submitted by: | Dr. Vittorio Servidori
General Manager
PENTAFERTE S.p.A
Loc. Nocella Statale 262
64012 Campli (Teramo), Italy
Tel: 011 39 0532 778811
Fax: 011 39 0532 778812 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | April 10, 2003 |
| Device Name: | PENTATRASFU™ Blood Transfusion Sets |
| Common Name: | Blood Transfusion Set |
| Classification Name: | Set, Blood Transfusion |
| Class: | 2 |
| Product Code: | BRZ |
| Regulation Number: | 21 CFR 880. 5440 |
| Predicative Device: | Tuta Healthcare Blood/Solution Administration Sets (K023039)
Baxter Healthcare Blood Transfusion Set (K924721) |
| Modifications: | There are no modifications to the device design that affect safety
and effectiveness of the PENTATRASFU™ Blood Transfusion Set |
1
SAFETY AND EFFICACY FOR PENTATRASFU™ BLOOD TRANSFUSION SETS
SUMMARY
(As Required by 21 CFR 807, 92)
Can Substantially Equivalence be established between the PENTATRASFU Blood Transfusion Sets and the Predicative devices?
Yes, the PENTATRASFU™ Blood Transfusion Sets are substantially equivalent to the predicative devices based on the following criteria:
- a. These Blood Transfusion Sets are used to administer blood from a container (plastic bag or glass bottle) to a patient's vascular system through a needle or Catheter inserted into a vein, same as the predicative devices.
- b. These Blood Transfusion Sets and the predicative devices have the same Instructions for Use: To administer Blood into a patient's vascular system.
- c. These Blood Transfusion Sets are manufactured with similar biocompatible materials as the predicative devices. PVC tubing, Polyethylene, White PVC, and Natural Rubber. Biocompatibility testing of these Blood Transfusion Sets showed the materials to be biocompatible for their intended use.
- d. These Blood Transfusion Sets have similar design and the same principle of operation as the Predicative Blood/Solution Administration Sets.
- e. These blood Transfusion Sets do not have new or different characteristics that those of the Predicative devices, and the descriptive characteristics of this Blood Transfusion Sets are sufficient to ensure equivalence to the Predicative devices.
- ﮨﻨ These Blood Transfusion Sets have been tested for performance as per recognized Standard Guidance Document ISO 1135-4 Second Edition 1998-03-15 Transfusion Equipment for Medical Use - Part 4 Transfusion Sets for Single Use (General Plastic Surgery/Gen. Hospital), which is the same standard that applies to the Predicative devices. The results of the Performance Testing showed that these Blood Transfusion Sets met the testing requirements as described on the ISO 1135-4 Recognized Guidance Document.
- g. Biocompatibility testing conforms to FDA recognized standard 10993.
2
K6-j/496
| Device Description | The PENTATRASFU™ Blood Transfusion Sets are Single Use, Non-
toxic, Sterile, Non-Pyrogenic devices used to administer Blood to a
patient's vascular system through a Needle or Catheter inserted into a
vein. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | To Administer Blood to the patient's vascular system. |
| Technological | The PENTATRASFU™ blood Transfusion Sets have the same
technological characteristics as the legally marketed predicative
Blood Transfusion Sets. |
| Testing: | The PENTATRASFU™ blood Transfusion Sets have been
subjected to performance and safety testing to verify mechanical properties
and functioning, as well as biocompatibility and sterility, using FDA recognized
Standards, where applicable |
.
3
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
Public Health Service
JUN 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pentaferte S.P.A C/O Mr. Victor Pereira Consultant Pentaferte S.P.A 7240 NW 63 Terrace Parkland, Florida 33067
Re: K041496
Trade/Device Name: PENTATRASFU™ Blood Transfusion Sets Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: BRZ Dated: May 31, 2005 Received: June 15, 2005
Dear Mr. Pereira:
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.
4
Page 2 - Mr. Pereira
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. or the rior of any 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 and insuits (= = = = = 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) rine reter 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), 11 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 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/industry/support/index.html.
Sincerely yours,
Sute y. Michael Davis.
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
5
INDICATIONS FOR USE
510(k) Number K041496
Device Name: PENTATRASFU™ Blood Transfusion Sets
INDICATIONS FOR USE: To administer Blood and Blood Derivatives into a patient's vascular system
Prescription Use
(21CFR 801 Subpart D)
AND/OR
Over- The Counter Use: (21 CFR Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Dovice Evaluation (ODE)
Amma Subbarao
(Division Sign-Off) (Division Sıgn-Off)
Division of Anesthesiology, General Hospital,
Division of Control, Dental Devices, or L Division of Anesthesiology
Infection Control, Dentral Devices 120419
510(k) Number:_