The SafetyTip™ Multi-Sample Needle and SafetyTing Blood Collection The Sarely In -- Mun-Sample thood collection. The safety sheath helps to System is to be used for vehous blood conceasing the needle before and after use.

Device Description

The Multi-Sample needle consists of a Cannula, Hub, Safety Sheath, Rubber Sleeve, and lower cover. The Multi-Sample needle consists of a hypodermic needle in sizes 18 Gauge to 22 gauge with lengths of 1" to 3 ½". It has a hinged cover/sheath that is pulled open by the user by pinching the sides to expose the needle. When closing there are two levels, first. Close the sheath over the needle by pressing the needle down against any hard surface. At this noint the needle may be re-opened by using the normal technique. To use the permanent locking system, close the sheath over the needle by pressing the needle down against any hard surface then, pressing the tip of the sheath with more force until the needle is lodged between the locking tabs, creating a permare rot lock. The SafetyTip™ Blood Collection System consists of a Cannula, Hub, Safety Sheath, Medical Surgical Grade Rubber Sleeve Holder and The Tube Holder. This is a "safety" device in that by using the permanent-locking feature, It may prevent accidental needlesticks. Its one-handed loosing motion is in compliance with the CAL-OSHA standards. When cloning the Safety Tip™ Blood Collection System there are two levels, first. close the sheath over the needle by pressing the needle down against any hard surface. At this point the needle may be re-opened by using the normal technique. To use the permanent locking system, close the sheath over the needle by pressing the needle down against any hard surface then, pressing the tip of the sheath with more force until the needle is lodged between the locking tabs, creating a permanent lock.

AI/ML Overview

The provided 510(k) summary for K993125, concerning the SafetyTip™ Multi-Sample Needle and SafetyTip™ Blood Collection System, explicitly states that the determination of substantial equivalence is NOT based on an assessment of clinical performance data.

Therefore, there is no study described within this document that proves the device meets any specific acceptance criteria related to its clinical performance. The submission relies solely on non-clinical data and comparison of device features, materials, and intended use to predicate devices already on the market.

Here's a breakdown based on your requested information, highlighting the absence of clinical study data:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
None defined in the document for clinical performance.	No clinical performance data reported.
(The submission focuses on substantial equivalence to predicate devices based on design and intended use, not on specific performance metrics.)	(The document states: "The determination of substantial equivalence is not based on a assessment of clinical performance data.")

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. No clinical test set was used for performance assessment.
Data Provenance: Not applicable. No clinical data was used for performance assessment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical test set with ground truth established by experts was used.

4. Adjudication method for the test set:

Not applicable. No clinical test set required adjudication.

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. An MRMC comparative effectiveness study was not done. The device is a blood collection needle and tube holder system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. The device is a physical medical device (needle and tube holder), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No ground truth based on clinical data was used for performance assessment. The "ground truth" for showing substantial equivalence would be the established safety and effectiveness of the legally marketed predicate devices, inferred from their market history and regulatory clearance.

8. The sample size for the training set:

Not applicable. No training set was used as this is a physical device, not an AI algorithm.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

In summary: K993125 is a 510(k) submission that seeks clearance based on substantial equivalence to existing predicate devices, primarily through a comparison of design, materials, and intended use. The document explicitly states that clinical performance data was not used to determine substantial equivalence. The "safety" aspect is highlighted through the inclusion of a safety sheath to prevent needlesticks, aligning with the safety features of some predicate devices. The study proving the device meets acceptance criteria, in this context, refers to the demonstration of substantial equivalence to predicate devices based on non-clinical assessment, rather than a clinical performance study with defined acceptance criteria and collected data.

Summary

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K993125

JUN 2 0 2000

Image /page/0/Picture/2 description: The image is a black and white logo. The logo consists of a globe on top of three vertical bars. The globe is shaded with a dot pattern. The three vertical bars are solid black and are of equal width.

SAFETY MEDICAL S: PPLY INTERNATIONAL. INC. 135 Beaver Street 4™ Floor Wal Tham, MA 02154 (781) 642-7171 Fax (781) 642-7373

"510 (k) Summary" as required by section 807.92 ( c )

807.92(a) (1)

Submitter's Name: Yovette Mumford-President of Safety Medical Supply International, Inc. 135 Beaver Street 4th Floor Waltham, MA 02452-8424 (781) 642-7171 Fax (781) 642-7373 Contact Name: Yovette Mumford or Geneva Burchell Date Summary was prepared September 10, 1999

807.92 (a) (2)

Trade Name: SafetyTip™ Multi-Sample Needle Common Name: Blood Collection Needle Classification Name: Needle, Hollow Double Lumen, All types;80 FMI Class II Device

Trade name: SafetyTip™ Blood Collection System

Common Name: Tube Holder Classification Name: Tube Holder JKA Class II Device

807.92(a)(3)

The legally marketed devices to which Safety Medical Supply International, Inc. claims equivalence:

(For the SafetyTip™ Multi-Sample Needle) "Punctur-Guard" Bio-Plexus

"Monoject" Sherwood

Becton Dickinson "Vacutainer"

(For the SafetyTip™ Blood Collection System)
Bio-Plexus	"Standard Needle Holder"
Sage	"Blood Needle Holder System"
Becton Dickinson	"Safety-Lok Needle"

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807.92(a)(4)

Description of the devices:

The Multi-Sample needle consists of a Cannula, Hub, Safety Sheath, Rubber Sleeve, and lower cover.

The Multi-Sample needle consists of a hypodermic needle in sizes 18 Gauge to 22 gauge with lengths of 1" to 3 ½". It has a hinged cover/sheath that is pulled open by the user by pinching the sides to expose the needle. When closing there are two levels, first. Close the sheath over the needle by pressing the needle down against any hard surface. At this noint the needle may be re-opened by using the normal technique. To use the permanent locking system, close the sheath over the needle by pressing the needle down against any hard surface then, pressing the tip of the sheath with more force until the needle is lodged between the locking tabs, creating a permare rot lock.

The SafetyTip™ Blood Collection System consists of a Cannula, Hub, Safety Sheath, Medical Surgical Grade Rubber Sleeve Holder and The Tube Holder. This is a "safety" device in that by using the permanent-locking feature, It may prevent accidental needlesticks. Its one-handed loosing motion is in compliance with the CAL-OSHA standards. When cloning the Safety Tip™ Blood Collection System there are two levels, first. close the sheath over the needle by pressing the needle down against any hard surface. At this point the needle may be re-opened by using the normal technique. To use the permanent locking system, close the sheath over the needle by pressing the needle down against any hard surface then, pressing the tip of the sheath with more force until the needle is lodged between the locking tabs, creating a permanent lock.

** The Multi Sample Needle and The Blood Collection Unit are designed to be used as "one" product, or used separately.

807.92(a)(5)

Intended Use: The SafetyTip™ Multi Sample Needle is a sterile, multisample single-use device for blood collection. The needle is designed with an attached safety sheath, which can be activated to sheath the needle immediately after venipuncture to provide protection from accidental needlesticks. The SafetyTip™ Multi-Sample Needle can be used with any tube holder to perform blood collection (phlebotomy) After use,

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immediately dispose of the Multi-Sample Needle in an approved Bio-Hazard container.

807.92(a)(5) continued

Intended Use: The SafetyTip™ Blood Collection System is a sterile, multisample needle, permanently attached to a sterile tube holder. The needle is used to draw blood from a vein and the tube holder holds the test tubes while the blood is drawn into the tubes. After blood collection, the tubes are then placed in the phlebotomy carriers or refrigeration units and the disposable SafetyTip™ Blood collection System is then discarded into an approved Bio-Hazard container.

807.92(a)(6)

There is one significant technological characteristic of our device compared to predicate devices in that the SafetyTip™ Multi-Sample Needle and the SafetyTip™ Blood Collection System contain a safety "sheath" that is intended to cover the needle after use and before disposal for healthcare worker protection.

807.92(b)(1)

The determination of substantial comparison of the device features, materials, and intended use. Please refer to the substantial equivalence table in this 510(k) submission for more specific details.

807.92(b)(2)

The determination of substantial equivalence is not based on a assessment of clinical performance data. We are planning to conduct clinical trials at medical facilities and institutions as soon as possible, and will submit any relevant information in the form of an addendum if needed. (# 3 of the 510(k) content and format states, "Clinical data is not needed for not t devices cleared by the 510(k) process." )

807.92(b)(3)

The conclusions drawn from the non-clinical data is that the SafetyTip™ Multi-Sample Needle and the SafetyTip™ Blood Collection System are substantially equivalent to the commercially available devices on the market todav.

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807.92(d) The FDA has made no requests at this point in the process of the application.

1977 - 1997 - 1997 - 1997

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Image /page/4/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2000

Ms. Geneva Burchell Safety Medical Supply International, Incorporated 69 Hickory Drive, 1st Floor Waltham, Massachusetts 02451-1011

Re : K993125 Trade Name: SafetyTip® Multi-Sample Needle and SafetyTip® Blood Collection System Regulatory Class: II Product Code: FMI Dated: April 5, 2000 Received: April 14, 2000

Dear Ms. Burchell:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Burchell

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" a

Sincerely yours,

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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510(k) Number if known):993125

Device Name: SafetyTip™ Multi-Sample Needle and SafetyTip™ Blood Collection System

Indications for use:

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

Concurrence of CDRH, Office of device evaluation (ODE)

Patricio Cucenite

(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices and General Hospida Hospida 2933

(Optional Format 3-10-98)

510(k) Number_

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).