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.

AI/ML Overview

The provided document describes the PENTATRASFU™ Blood Transfusion Sets and their substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML device. Therefore, the information required for this request (AI/ML acceptance criteria, study details, expert involvement, etc.) is not present in the provided text.

However, I can extract the information related to the performance testing and compliance with standards as described for this medical device.

Here's the information as best as can be extracted from the provided text, focusing on the performance criteria and testing mentioned for the PENTATRASFU™ Blood Transfusion Sets:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Performance based on ISO 1135-4 Second Edition 1998-03-15 Transfusion Equipment for Medical Use - Part 4 Transfusion Sets for Single Use	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 based on FDA recognized standard 10993	Biocompatibility testing of these Blood Transfusion Sets showed the materials to be biocompatible for their intended use.
Sterility	The device is described as Sterile.
Non-Pyrogenic	The device is described as Non-Pyrogenic.
Non-toxic	The device is described as Non-toxic.
Mechanical Properties and Functioning	The PENTATRASFU™ blood Transfusion Sets have been subjected to performance and safety testing to verify mechanical properties and functioning.
Substantial Equivalence to Predicate Devices	Substantially equivalent based on same intended use, instructions, biocompatible materials (PVC tubing, Polyethylene, White PVC, Natural Rubber), similar design, same principle of operation, and no new or different characteristics that affect safety and effectiveness.

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 provided in the document. The document refers to "Performance Testing" but does not specify sample sizes or data provenance.

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 provided in the document. The testing mentioned refers to compliance with a standard (ISO 1135-4) and biocompatibility, which typically involve laboratory testing, not expert-adjudicated ground truth as would be relevant for an AI/ML device.

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

This information is not applicable/not provided. The assessment of this medical device is based on compliance with recognized standards and laboratory testing, not a human reader adjudication process.

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/not provided. This device is a blood transfusion set, not an AI/ML-driven diagnostic or assistive device that would involve human readers or AI assistance.

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

This information is not applicable/not provided. This device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this device's performance is established through compliance with recognized international standards (ISO 1135-4 for performance, ISO 10993 for biocompatibility) and direct physical/material testing, rather than clinical outcomes or expert consensus on diagnostic interpretations.

8. The sample size for the training set

This information is not applicable/not provided. This device is a physical product and does not have a "training set" in the context of AI/ML.

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

This information is not applicable/not provided. This device is a physical product and does not have a "training set" or "ground truth" in the context of AI/ML.

Summary

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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 ServidoriGeneral ManagerPENTAFERTE S.p.ALoc. Nocella Statale 26264012 Campli (Teramo), ItalyTel: 011 39 0532 778811Fax: 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 safetyand effectiveness of the PENTATRASFU™ Blood Transfusion Set

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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.

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K6-j/496

Device Description	The PENTATRASFU™ Blood Transfusion Sets are Single Use, Non-toxic, Sterile, Non-Pyrogenic devices used to administer Blood to apatient's vascular system through a Needle or Catheter inserted into avein.
Intended Use:	To Administer Blood to the patient's vascular system.
Technological	The PENTATRASFU™ blood Transfusion Sets have the sametechnological characteristics as the legally marketed predicativeBlood Transfusion Sets.
Testing:	The PENTATRASFU™ blood Transfusion Sets have beensubjected to performance and safety testing to verify mechanical propertiesand functioning, as well as biocompatibility and sterility, using FDA recognizedStandards, where applicable

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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.

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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

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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:_

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.