SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM

• K Number: K981973
• Device Name: SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
• Manufacturer: RAM SCIENTIFIC
• Date Cleared: 1998-09-03 ( 90 days)
• Product Code: JKA
• Regulation Number: 862.1675
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: K896206 , K833475 , K931368
• Predicate For: N/A

Intended Use

The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for testing.
The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for diagnostic hematology testing.

Device Description

The SAFE-T-FILL® Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. It is a non-invasive device. SAFE-T-FILL® is a 100 % plastic preassembled system made up of 4 components. A capillary end-to-end tube, a colored sleeve which holds the capillary, a microtube, and a cap. The sleeve and cap come in anticoagulant that is contained within the microtube. Blood is collected into the capillary tube and allowed to flow into the microtube. The tube is capped, mixed and then processed by the user organization.

AI/ML Overview

This 510(k) submission (K981973) for the SAFE-T-FILL® Capillary Blood Collection System is a premarket notification for a medical device seeking substantial equivalence to predicate devices, not a study presenting acceptance criteria and performance data for a new AI or diagnostic algorithm.

Therefore, the requested information cannot be extracted from the provided text, as it describes a product with a physical function (capillary blood collection) and seeks regulatory approval based on material and functional similarities to existing devices, not on diagnostic performance against specific criteria. There is no mention of an algorithm, AI, or diagnostic performance metrics typically associated with such studies.

Specifically:

1. There is no table of acceptance criteria and reported device performance related to diagnostic accuracy because this is a physical blood collection device.
2. No sample size for test sets or data provenance is mentioned as this is not a study evaluating diagnostic performance.
3. No experts were used to establish ground truth because there is no diagnostic outcome to evaluate.
4. No adjudication method is applicable.
5. No MRMC comparative effectiveness study was done as there is no AI or diagnostic algorithm.
6. No standalone performance study was done as there is no algorithm.
7. No ground truth type is applicable.
8. No sample size for the training set is applicable.
9. No ground truth for the training set was established.

The document primarily focuses on:

• Device Description: What the SAFE-T-FILL® system is and how it works.
• Intended Use: For drawing capillary blood for testing.
• Predicate Devices: Comparison to existing legally marketed devices (StatSampler®, CapiJect®, Microtainer®).
• Substantial Equivalence: Arguing that the new device is as safe and effective as predicate devices based on design and function similarities.

The table in the document (page 1) lists characteristics of the SAFE-T-FILL® and predicate devices, which serve to demonstrate substantial equivalence, not diagnostic performance against acceptance criteria.

Summary

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KG81973

Image /page/0/Picture/1 description: The image shows the logo for RAM Scientific, Inc. The logo features a stylized ram's head inside a letter "R" on the left. To the right of the ram's head is the text "RAM SCIENTIFIC, INC." Below the company name is the address "P.O. Box 586, Needham, MA 02194".

P.O. Box 586, Needham, MA 02194 Phone: [phone] Fax: [phone]

3 1998 SEP

510(k) SUMMARY

June 5, 1998

Submitter:	RAM Scientific, Inc.P.O. Box 586Needham, Massachusetts 02194Phone [phone]Fax [phone]
Contact Person:	Monique MuriRAM Scientific, Inc.Phone [phone]Fax [phone]
Trade Name:	SAFE-T-FILL® Capillary Blood Collection System
Common Name:	Capillary blood collection system
Classification Name:	Blood Specimen Collection Device
Predicate Device:	StatSampler® (K896206); CapiJect® Capillary BloodCollection System (K833475); and Microtainer® Tube withEDTA and Microgard™ Closure (K931368).
Description:	The SAFE-T-FILL® Capillary Blood Collection System is acollection device used to draw capillary blood from the fingeror heelstick. It is a non-invasive device. SAFE-T-FILL® is a100 % plastic preassembled system made up of 4 components.A capillary end-to-end tube, a colored sleeve which holds thecapillary, a microtube, and a cap. The sleeve and cap come inanticoagulant that is contained within the microtube. Blood iscollected into the capillary tube and allowed to flow into themicrotube. The tube is capped, mixed and then processed bythe user organization.
Intended Use:	The SAFE-T-FILL® Capillary Blood Collection System isindicated for the drawing of blood via capillary action from afinger or heelstick to be placed in a microtube for the purposesof obtaining a blood sample for testing.

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Characteristic	SAFE-T-FILL®	StatSampler®	CapiJect®	Microtainer®
Combination capillarytube and microtube.	Yes	Yes	No	No
Available with differentadditives oranticoagulants	Yes	Yes	Yes	Yes
All Components Plastic	Yes	No	Yes	Yes
Used to collect,Anticoagulate and StoreSkin Puncture BloodSpecimens	Yes	Yes	Yes	Yes
Similar HematologicalDeterminations	Yes	Yes	Yes	Yes
Fill Lines	125μl, 150 μl, &200 μl	100μl & 200μl	250μl, 500μl& 625μl	500 μl
Preassembled	Yes	No	Yes	Yes
Sterile	No	No	No	No

Summary of Similarities and Differences of Predicate Devices

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

SEP 3 1698

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ram Scientific C/O Mr. Geoffrey M. Levitt Venable, Baetjer, Howard & Ceviletti, LLP 1201 New York Avenue, N.W., Suite 1000 Washington, D.C. 20005-3917

Re: K981973/S1

Trade Name: SAFE-T-FILL® Capillary Blood Collection System Regulatory Class: II Product Code: JKA Dated: July 31, 1998 Received: July 31, 1998

Dear Mr. Levitt:

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 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 regulations.

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Page 2

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbrandinq 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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INDICATIONS FOR USE

The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of The SATE-T-THEE® Capillary 21000 On heelstick to be placed in a microtube for the olood via capinary asaon not sample for diagnostic hematology testing.

Peter E. Maples

(Division Sign-Off) (Elicion of Clinical Laboratory Devices
510(k) Number 510(k) Number -

Rv i

Regulation Number and Section

§ 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.