NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505

K092246 · Nipro Medical Corporation · LHI · Nov 12, 2009 · General Hospital

Device Facts

• Record ID: K092246
• Device Name: NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505
• Applicant: Nipro Medical Corporation
• Product Code: LHI · General Hospital
• Decision Date: Nov 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

The NIPRO Needleless Transfer Device is a sterile device for the aseptic transfer of solutions from container to container or reconstituting medications.

Device Story

The Nipro Needleless Transfer Device is a sterile, single-use, injection-molded plastic device designed for the aseptic transfer of liquids. It features two capped spikes on opposite ends of a main body, optionally including vial closure adapters to stabilize containers during mixture. The device facilitates the transfer of sterile water from a source vial into an evacuated vial containing lyophilized medication for reconstitution. It is intended for use in clinical settings to ensure aseptic handling during fluid transfer. By providing a closed, needleless pathway, the device reduces the risk of contamination and needle-stick injuries during medication preparation, benefiting both the healthcare provider and the patient.

Clinical Evidence

No clinical data. Bench testing only, including dimensional, mechanical, operational, chemical, and biocompatibility testing.

Technological Characteristics

Single-piece injection-molded plastic body; two capped spikes; optional vial closure adapters; sterile; single-use; latex-free; non-toxic; non-pyrogenic.

Indications for Use

Indicated for aseptic transfer of solutions between containers or for the reconstitution of medications.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MSI Transflow (K972117)

Submission Summary (Full Text)

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K092246

Image /page/0/Picture/1 description: The image shows the logo for Nipro Medical Corporation. The logo consists of two interlocking circles on the left, followed by the word "NIPRO" in large, bold letters. Below "NIPRO" are the words "MEDICAL CORPORATION" in smaller letters. The logo is black and white.

3150 NW 107th Avenue, Miami FL 33172 Tel: [phone] Fax: [phone]

## 510(k) Summary NIPRO Needleless Transfer Device

NOV 12 2009

## 807.92(a) (1)

Jessica Oswald, Regulatory Affairs Specialist Contact Person: Date of summary preparation: July 22, 2009

#### 807.92(a) (2)

Trade Name: NIPRO Needleless Transfer Device Common Name: TRANSFER NEEDLE Classification Name: Set, IV, Fluid transfer Regulation Number: 21 CFR part 880.5440 Regulatory Class: II Panel: 80 Product Code: LHI

## 807.92(a) (3)

Legally marketed substantial equivalent device: K972117: MSI Transflow

## 807.92(a) (4)

Description of device:

The Nipro Needleless Transfer Device with or without 20mm vial closure adapters is a sterile, single-use needleless liquid transfer device with the intent of transferring sterile water from its vial into an evacuated vial containing lyophilized product requiring reconstitution.

This device consists of a single piece injection molded main body with 2 capped spikes on both ends. The device is provided with and without 2 adapters used for setting at the mouth of the solution bottle in order to stabilize the container at the time of mixture.

The device is sterile, single-use only, latex-free, non-toxic and non-pyrogenic.

## 807.92(a) (5)

Indications for Use:

The NIPRO Needleless Transfer Device is a sterile device for the aseptic transfer of solutions from container to container or reconstituting medications.

Nipro Transfer Device 5 510k summary

-5.1-

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### 807.92(a) {6)

Comparison of technological characteristics:

The NIPRO Needleless Transfer Device is substantially equivalent to the predicate device in the following technological characteristics -

- . Design
- Physical characteristics .
- Basic Scientific Technology .
- Intended Use �

## 807.92(b) (1)

Non-clinical tests performed and included in this submission include:

- Dimensional .
- Mechanical .
- . Operational
- � Chemical
- . Biocompatibility

## 807.92(b) (3)

Conclusions drawn from non-clinical and clinical tests:

The results of the non-clinical tests and the comparison of technological characteristics with the predicate device demonstrate that the NIPRO Needleless Transfer Device performs equivalent to the predicate device and is safe and effective when used as intended.

NIPRO Needleless Transfer Device 5 510k summary

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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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Jessica Oswald Regulatory Affairs Specialist Nipro Medical Corporation 3150 NW 107th Avenue Miami, Florida 33172

NOV 12 2008

Re: K092246

Trade/Device Name: NIPRO Needleless Transfer Device Regulation Number: 21CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: October 6, 2009 Received: October 9, 2009

Dear Ms Oswald:

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 markéted 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 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 - Ms. Oswald

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. 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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# Indications for Use

510(k) Number (if known):

Device Name: NIPRO Needleless Transfer Device

Indications For Use:

The NIPRO Needleless Transfer Device is a sterile device for the aseptic transfer of solutions from container to container or reconstituting medications.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eunice Diaz

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

NIPRO Needleless Transfer Device 4 Indications for Use

510(k) Number: Kog 22 4b -4.1-