(107 days)
The NIPRO Needleless Transfer Device is a sterile device for the aseptic transfer of solutions from container to container or reconstituting medications.
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.
The NIPRO Needleless Transfer Device is a sterile, single-use needleless liquid transfer device intended for transferring sterile water from a vial into an evacuated vial containing lyophilized product for reconstitution, or for aseptic transfer of solutions between containers.
Here's an analysis of the provided information regarding its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document primarily focuses on non-clinical tests to establish substantial equivalence rather than specific performance metrics against pre-defined numerical acceptance criteria for a "device." Instead, the criteria are related to the successful execution of various tests aligning with known good manufacturing practices and device functionality.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Design Equivalence | Substantially equivalent to predicate device (K972117: MSI Transflow) |
| Physical Characteristics Equivalence | Substantially equivalent to predicate device |
| Basic Scientific Technology Equivalence | Substantially equivalent to predicate device |
| Intended Use Equivalence | Substantially equivalent to predicate device |
| Dimensional Tests | Performed; results supported substantial equivalence |
| Mechanical Tests | Performed; results supported substantial equivalence |
| Operational Tests | Performed; results supported substantial equivalence |
| Chemical Tests | Performed; results supported substantial equivalence |
| Biocompatibility Tests | Performed; results supported substantial equivalence |
| Overall Safety and Effectiveness | Demonstrated to perform equivalently to the predicate device and is safe and effective when used as intended. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each non-clinical test (Dimensional, Mechanical, Operational, Chemical, Biocompatibility). These tests are typically conducted on a representative sample of finished product. The data provenance is presumed to be from tests performed by the manufacturer (Nipro Medical Corporation) in support of their 510(k) submission. No information on country of origin of data or whether tests were retrospective or prospective is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable and therefore not provided in the document. For non-clinical device testing, "ground truth" is typically established by engineering specifications, regulatory standards, and validated test methods, not by expert consensus in the same way it would be for diagnostic AI.
4. Adjudication Method for the Test Set:
Not applicable. The non-clinical tests described do not involve human adjudication in the context of interpreting results in a consensus approach. Test results are compared against pre-defined specifications or predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving AI or human interpretation) to assess clinician performance with and without AI assistance. The NIPRO Needleless Transfer Device is a mechanical medical device, not a diagnostic tool requiring human interpretation or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
No, a standalone (algorithm only) performance assessment was not done. This is not relevant for a mechanical medical device.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests was established by:
- Engineering Specifications: Designed parameters and tolerances for the device.
- Regulatory Standards: Applicable standards for safety, performance, and biocompatibility of medical devices (e.g., ISO standards, FDA guidance documents).
- Predicate Device Performance: The established performance characteristics of the legally marketed predicate device (K972117: MSI Transflow) served as a benchmark for comparison to demonstrate substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set for this type of medical device.
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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: 305.599.7174 Fax: 305.592.4621
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 (800) 638-2041 or (301) 796-7100 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-
§ 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.