(314 days)
The Quick Sampler Holder is intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests
The Quick Sampler Holder is a non-contacting patient device. It is intended to be used in conjunction with a vacuum blood collecting vessel and bloodlines with y-ports, for blood banking. The Quick Sampler Holder consists of a double ended 18 gauge needle attached to a blood tube holder. The proximal needle tip, which is inserted into the yport, is blunt to prevent accidental needlesticks; the distal end, inside the holder, is sharp and is covered by a rubber sleeve to prevent blood loss during vial replacement/sample collection.
The provided text is a 510(k) summary for the Nipro Quick Sampler Holder, which is a medical device for blood specimen collection. This document does not describe a study using a device that meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.
Instead, it's a regulatory submission demonstrating substantial equivalence to a predicate device (ITL Samplok Luer Kit, K021941) based on non-clinical performance testing. Therefore, most of the requested information regarding ground truth, expert consensus, MRMC studies, and sample sizes for test/training sets is not applicable to this type of submission.
Here's a breakdown of the available information based on your request, with an explanation of why certain categories are not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists "Performance characteristics" that were tested, but it does not provide specific numerical acceptance criteria or detailed reported performance values for each characteristic. It only states that the device was found to be "substantially equivalent" based on these tests.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Integrity test of tamper sealing | Not specified (implied to have met requirements for substantial equivalence) |
| Rubber sleeve functional tests | Not specified (implied to have met requirements for substantial equivalence) |
| Hub-needle functional tests | Not specified (implied to have met requirements for substantial equivalence) |
| Hub-Holder functional tests | Not specified (implied to have met requirements for substantial equivalence) |
| Chemical characteristics | Not specified (implied to have met requirements for substantial equivalence) |
| Microbiological characteristics | Not specified (implied to have met requirements for substantial equivalence) |
| Dimensional characteristics | Not specified (implied to have met requirements for substantial equivalence) |
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 "non-clinical tests" but does not detail the methodology, sample sizes, or provenance of materials used for these tests. The tests would likely be performed in a lab setting, not involving human subjects or data from a country of origin in the way a clinical study would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth, expert consensus, and expert qualifications are relevant to studies involving diagnostic accuracy or classification tasks, typically for AI/ML devices or clinical trials. This submission focuses on the mechanical and functional performance of a blood collection device through non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in studies where human readers interpret data (e.g., medical images) and their agreement or disagreement needs to be resolved to establish ground truth. This is a non-clinical device performance submission.
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
No such study was done. This is a medical device for blood collection, not an AI/ML-powered diagnostic tool, and the submission explicitly states "No clinical testing required or submitted with this application."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable. The "truth" for these non-clinical tests would be defined by engineering specifications, material standards, and performance metrics (e.g., seal integrity, dimensions, functionality checks) rather than expert consensus on a clinical outcome or pathology.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" as this is not an AI/ML device.
Summary of Device and Acceptance:
The Nipro Quick Sampler Holder's acceptance by the FDA (as indicated by the 510(k) clearance) is based on demonstrating substantial equivalence to a predicate device (ITL Samplok Luer Kit, K021941) through non-clinical performance characteristics testing. The key difference between the Quick Sampler Holder and its predicate is a blunt proximal tip versus a luer tip. The submission asserts that "The Quick Sampler Holder is identical to the predicate in terms of indications for use and mode of operation" and "substantially equivalent ... in terms of functional, mechanical and material specifications." No clinical studies were required or submitted.
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Image /page/0/Picture/1 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized, intertwined symbol on the left, followed by the word "NIPRO" in bold, sans-serif font. Below "NIPRO" is the text "MEDICAL CORPORATION" in a smaller, sans-serif font.
3150 NW 107th Avenue, Miami FL 33172 Tel: 305.599.7174 Fax: 305.592.4621
DEC 2 7 2012
510(k) Summary - Quick Sampler Holder
807.92(a) (1)
Contact Person:
Jessica Oswald Regulatory Affairs Specialist
Date of summary preparation:
January 19, 2012
807.92(a) (2)
Trade Name: Quick Sampler Holder
Common Name: Blood specimen collection device
Classification Name: tubes, vials, systems, serum separators, blood collection Regulation Number: 862.1675
Regulatory Class: II
Panel: Clinical Chemistry ·
Product Code: JKA
807.92(a) (3)
Legally marketed substantial equivalent device: ITL Samplok Luer Kit (K021941)
807.92(a) (4)
Description of device:
The Quick Sampler Holder is a non-contacting patient device. It is intended to be used in conjunction with a vacuum blood collecting vessel and bloodlines with y-ports, for blood banking. The Quick Sampler Holder consists of a double ended 18 gauge needle attached to a blood tube holder. The proximal needle tip, which is inserted into the yport, is blunt to prevent accidental needlesticks; the distal end, inside the holder, is sharp and is covered by a rubber sleeve to prevent blood loss during vial replacement/sample collection.
807.92(a) (5)
Indications for Use:
The Quick Sampler Holder is intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests
807.92(a) (6)
Comparison of technological characteristics:
The Quick Sampler Holder is identical to the predicate in terms of indications for use and mode of operation. It is substantially equivalent to the predicate in terms of functional, mechanical and material specifications. The only technological difference between the
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two devices is the proximal tip. The quick Sampler holder has a blunt tip, whereas, the ITL Samplok has a luer tip.
807.92(b) (1)
Non-clinical tests submitted:
Performance characteristics: Integrity test of tamper sealing, Rubber sleeve functional tests, Hub -needle functional tests, Hub -Holder functional tests, Chemical and microbiological characteristics and Dimensional characteristics.
807.92(b) (2)
Clinical tests submitted:
No clinical testing required or submitted with this application.
807.92(b) (3)
Conclusions drawn from non-clinical and clinical tests:
Based on the testing described above, we believe the Quick Sampler Holder to be substantially equivalent to ITL Samplok, in terms of safety and effectiveness for its · intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three abstract figures or lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 27, 2012
Ms. Jessica Oswald-McLeod, ASQ CQA Regulatory Affairs Specialist Nipro Medical Corporation 3150 North West, 107th Avenue MIAMI FL 33172
Re: K120490
Trade/Device Name: Quick Sampler Holder Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA Dated: September 11, 2012 Received: September 13, 2012
Dear Ms. Oswald-McLeod:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Internations administered by other Federal agencies. You must or any I edolul statutes and regulaments, 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 forth in the qualis) of bections (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 note the regalations 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
349D
Device Name: Quick Sampler Holder
Indications for Use:
The Quick Sampler Holder is intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
igitally signed by Sajjad H. Syed Saijad H. Syed DA, ou=People, cn=Sajjad H. Syed 0200300 100.1.1=200060174
(Division Sign-Off) (Division Sign-Off)
Division of Anesthestology, General Hospital Division Control, Dental Devices
K120490 510(k) Number;
Quick Sampler Holder
-4.1-
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.