A properly placed MDC Safe Step Safety Blood Collection Needle System incorporates a retractable needle safety mechanism to minimize needle stick injuries when used to access a vein to obtain blood samples.

Device Description

The Safe Step Safety Blood Collection Needle System consists of four separate components: a blood collection needle assembly; an evacuated tube adapter; a front protective cap; and a rear protective cap.

The Safe Step Safery Blood Collection Needle System is a standard Blood Collection Needle System with the additional feature of a retractable needle. The needle safety mechanism can be activated by lifting the thumb pad (located on the rear piece of the tube adapter) upwards and forward, relative to the two finger tabs on the tube adapter front piece, after removing the last blood sample tube.

After needle retraction, the device is disposed of according to routine procedure in a sharps container.

AI/ML Overview

The provided text describes a traditional medical device (a blood collection needle system) and its regulatory clearance process, not an AI/ML-driven device. Therefore, many of the requested elements pertaining to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment for AI, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable or mentioned in this document.

However, I can extract information related to the device's acceptance criteria and how "performance data" proved it met them, based on the provided text.

Acceptance Criteria and Device Performance for Safe Step Safety Blood Collection Needle System

The "Safe Step Safety Blood Collection Needle System" is a blood collection needle system with an added safety feature: a retractable needle mechanism designed to minimize needle stick injuries.

The document indicates that the device's acceptance was based on demonstrating substantial equivalence to a predicate device and meeting functional requirements and specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance/Evidence
Intended Use	Substantially equivalent to existing blood collection needle systems for: - Providing vein access for blood specimen collection using an evacuated blood collection tube. - Incorporating a safety feature to cover the needle after use.	- "The Safe Step Safety Blood Collection Needle System is substantially equivalent to other Blood Collection Needle Systems currently in commercial distribution by BioPlexus, Inc. in terms of the intended use as a Blood Collection Needle System, providing vein access for the purpose of obtaining blood specimens using an evacuated blood collection tube, and the incorporation of a safety feature to cover the needle after use." (Section 10.5) - The device incorporates "a retractable needle safety mechanism to minimize needle stick injuries when used to access a vein to obtain blood samples." (Section 10.6)
Technological Characteristics	Similar to the predicate device (Bio-Plexus, Inc. Punctur-Guard Blood Collection Needle System) in terms of: - Providing vein access to collect blood specimens. - Including a user-activated feature to cover the needle after use. - Differences in physical appearance and materials not affecting relative safety or effectiveness.	- "The Safe Step Safety Blood Collection Needle System has the same technological characteristics as the Punctur-Guard Blood Collection Needle System. Both devices provide vein access to collect blood specimens and include a user activated feature to cover the needle after use." (Section 10.7) - "Differences that exist between these systems relating to physical appearance and materials do not affect the relative safety or effectiveness of the devices." (Section 10.5)
Functional Requirements & Specifications	The device must meet its defined functional requirements and specifications. (Specific functional details are not provided in the summary, but are implied.)	- "Performance data indicate that the Safe Step Safety Blood Collection Needle System meets the functional requirements and specifications of this device." (Section 10.8) (Note: The specific performance data, test methods, or quantified results are not detailed in this summary document.)

Since this is a medical device clearance and not an AI/ML device, the following points are not applicable or the information is not provided in the document:

Sample size used for the test set and the data provenance: Not applicable; this is for a physical device, not an AI model. Performance data is only vaguely mentioned as being present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; ground truth in the AI sense is not relevant here. The "ground truth" for this device would be its ability to perform its mechanical function (retraction, blood collection) reliably, which would be measured through engineering performance tests.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K973012

NOV - 5 1997

SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 10:

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SUBMITTER INFORMATION 10.1

Company Name:

MDC Research Ltd.

Company Address:

2810 Bunsen Avenue Ventura, California 93003

Telephone:

Contact Person:

(805) 339-0375

James M. Donegan Chief Executive Officer Chairman

Date Prepared:

August 11, 1997

DEVICE IDENTIFICATION 10.2

Common/Usual Name:

Blood Collection Needle System

Proprietary Name:

Safe Step Safety Blood Collection Needle System

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IDENTIFICATION OF PREDICATE DEVICE 10.3

The Safe Step Safety Blood Collection Needle System, with its components, is substantially equivalent to the following previously cleared and currently marketed device:

Bio-Plexus, Inc. Punctur-Guard Blood Collection Needle System, 510(k) #K895024, cleared on September 21, 1990.

DEVICE DESCRIPTION 10.4

After needle retraction, the device is disposed of according to routine procedure in a sharps container.

SUBSTANTIAL EQUIVALENCE 10.5

The Safe Step Safety Blood Collection Needle System is substantially equivalent to other Blood Collection Needle Systems currently in commercial distribution by BioPlexus, Inc. in terms of the intended use as a Blood Collection Needle System,

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providing vein access for the purpose of obtaining blood specimens using an evacuated blood collection tube, and the incorporation of a safety feature to cover the needle after use.

The technical characteristics are similar to those of the predicate device. Differences that exist between these systems relating to physical appearance and materials do not affect the relative safety or effectiveness of the devices.

INTENDED USE 10.6

TECHNOLOGICAL CHARACTERISTICS 10.7

The Safe Step Safety Blood Collection Needle System has the same technological characteristics as the Punctur-Guard Blood Collection Needle System. Both devices provide vein access to collect blood specimens and include a user activated feature to cover the needle after use.

PERFORMANCE DATA 10.8

Performance data indicate that the Safe Step Safety Blood Collection Needle System meets the functional requirements and specifications of this device.

510(K) CHECKLIST 16.9

This notification contains all of the information required by 21 CFR 807.87. A.

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completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle or other bird, with its wings spread and its head facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol L. Patterson Official Correspondent MDC Research Ltd. 2810 Bunsen Avenue Ventura, California 93003

NOV - 5 1997

Re : K973012 Safe Step™ Blood Collection Needle System Trade Name: Regulatory Class: II Product Code: FMI Dated: August 11, 1997 Received: August 13, 1997

Dear Ms. Patterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Patterson

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Clus. L/m
Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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MDC RESEARCH LTD AMENDMENT TO 510(K) K973027

INDICATIONS FOR USE

510(k) Number: K973027

MDC Safe Step Safety Blood Collection Needle System Device Name:

Indications For Use:

(Per 21 CFR 801.109)

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Guarente
(Division Sign Off)
Division of Dental, Infection Control,
and Hospital Devices
K973012

Prescription Use		OR	Over-The-Counter Use
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Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).