BLOOD TRANSFUSION SET

• K Number: K083349
• Device Name: BLOOD TRANSFUSION SET
• Manufacturer: SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
• Date Cleared: 2009-04-10 ( 148 days)
• Product Code: BRZ
• Regulation Number: 880.5440
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: K041496
• Predicate For: N/A

Intended Use

Blood Transfusion Set is 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.

Device Description

The proposed device is plastic, disposable and sterile blood transfusion set, which is intended to be used to administer the blood from the container to a patient's vascular system through a needle or catheter inserted into a vein via gravity method.

The blood transfusion set consists of protective cap of the closure-piercing device, closure piercing device, tubing, drip, flow regulator, transfusion needle and needle sheath. In addition, there are two kinds of the transfusion set, one has a drug-adding feature and the other hasn't.

There are two specifications of transfusion needle, which are 0.9# transfusion needle and 1.2# transfusion needle.

The proposed device is provided sterilized.

AI/ML Overview

The provided text describes a 510(k) submission for a Blood Transfusion Set, and thus there is no information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a premarket notification for a medical device seeking substantial equivalence to a predicate device.

Specifically:

• No acceptance criteria or device performance table is provided. The document states that "Laboratory testing was conducted to validate and verify that Blood Transfusion Set met all design specifications and was substantially equivalent to the predicate device," but it does not specify what those design specifications or acceptance criteria were, nor does it report specific performance metrics.
• No information on sample size for test sets or data provenance is available. No clinical or performance study details are included in this summary.
• No information on experts for ground truth or adjudication methods is available. There is no mention of a ground truth in the context of this device's submission, as it relates to a physical device rather than an AI or diagnostic algorithm.
• No MRMC comparative effectiveness study or standalone algorithm performance study was mentioned. These types of studies are typically relevant for AI/ML-based diagnostic devices, which is not the case here.
• The type of ground truth used is not applicable/not mentioned. For a physical device like a blood transfusion set, "ground truth" would not be established in the same way as for a diagnostic algorithm. The validation would likely involve engineering and biocompatibility testing against predefined standards.
• No information on training set sample size or how ground truth was established for a training set is available. This is not relevant for the type of device described.

In summary, the provided document is a 510(k) summary for a Blood Transfusion Set, focusing on its description, intended use, and substantial equivalence to a predicate device, rather than detailed performance studies or AI-specific validation criteria.

Summary

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Premarket Notification 510(k) Submission - Chapter VI Device Description Report No .: A2008-010-035

Chapter III 510(k) Summary

APR 】0 2009

Blood Transfusion Set

As required by 21 CFR 807.92(k)

The assigned 510(k) Number is: K083349

• 1. Date Prepared: November 05, 2008;
• 2. Sponsor Information

ShanDong WeiGao Group Medical Polymer Co., Ltd No.312 Shichang Road, Weihai City Shangdong, 264209, China

Contact Person: Mrs. Zhao Suxia, Quality Manager Tel: [phone] Fax: [phone] E-Mail: [e-mail]

• 3. Submission Correspondent
     Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongshan Zhongxin Mansion No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China
• 4. Device Name and Classification:
     Device Trade Name: Blood Transfusion Set Device Common Name: Blood Transfusion Set Device Classification Name: Set, blood transfusion

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K083349
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Premarket Notification 510(k) Submission - Chapter VI Device Description Report No .: A2008-010-035

Product Code: BRZ Regulation Number: 880.5440 Device Class: II

• 5. Predicate Device Identification: PENTATRASFU Blood Transfusion Sets K-number: K041496
• 6. Intended Use:

Blood Transfusion Set is 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.

• 7. Device Description:
     The proposed device is plastic, disposable and sterile blood transfusion set, which is intended to be used to administer the blood from the container to a patient's vascular system through a needle or catheter inserted into a vein via gravity method.

The blood transfusion set consists of protective cap of the closure-piercing device, closure piercing device, tubing, drip, flow regulator, transfusion needle and needle sheath. In addition, there are two kinds of the transfusion set, one has a drug-adding feature and the other hasn't.

There are two specifications of transfusion needle, which are 0.9# transfusion needle and 1.2# transfusion needle.

The proposed device is provided sterilized.

• 8. Test Conclusion
     Laboratory testing was conducted to validate and verify that Blood Transfusion Set met all design specifications and was substantially equivalent to the predicate device.
• 9. Substantially Equivalent Conclusion: The proposed device, Blood Transfusion Set, is substantially equivalent to the predicate device.

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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 stylized eagle with three overlapping wing segments, representing health, human services, and the people served by the department. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shan Dong Wei Gao Group Medical Polymer Products C/o Ms. Diana Hong General Manager Shanghai Midlink Business Consulting Company Limited Suite 8D, Zhongxin Zhongshan Mansion No. 19, Lane 999 Zhong Shan Nan Er Road Shanghai, CHINA 200030

APR 1 0 2009

Re: K083349

Trade/Device Name: Blood Transfusion Set Regulation Number: 21 CFR 880.5440 Regulatory Class: II Product Code: BRZ Dated: March 27, 2009 Received: March 31, 2009

Dear Ms. Hong:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Ms. Hong

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony, O. Awaton ber

Susan Runher, D.D.S., MA Acting 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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Indication for Use

510(k) Number:

K08349

Device Name: Blood Transfusion Set

Indications for Use:

Blood Transfusion Set is 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.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(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.