(36 days)
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 testing.
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 different colors which identify the general type of additive or 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.
The provided document is a 510(k) summary for the SAFE-T-FILL® Capillary Blood Collection System, a blood specimen collection device. The submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with quantifiable metrics. Therefore, the requested information regarding acceptance criteria, study details, and expert involvement is largely not explicitly stated in the provided text.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of acceptance criteria with corresponding performance results in a quantifiable manner, as might be expected for an AI/software device. Instead, the "performance" is assessed through a comparison of characteristics and intended use with predicate devices to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | SAFE-T-FILL® Performance (Reported) |
|---|---|---|
| Combination capillary tube and microtube | Yes (similar to StatSampler®) | Yes |
| Available with different additives or anticoagulants | Yes (similar to all predicates) | Yes |
| All Components Plastic | Yes (similar to CapiJect® & Microtainer®) | Yes |
| Used to collect, Anticoagulate and Store Skin Puncture Blood Specimens | Yes (similar to all predicates) | Yes |
| Similar Hematological Determinations | Yes (similar to all predicates) | Yes |
| Fill Lines | Range covering 100μl to 625μl (across predicates) | 125μl, 150μl, & 200μl |
| Preassembled | Yes (similar to CapiJect®) | Yes |
| Sterile | No (similar to all predicates) | No |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not explicitly stated in the provided document. It describes the device and its intended use, along with a comparison to predicate devices, but no specific test set or study data is presented.
- Data provenance: Not applicable as no specific test set data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific test set with ground truth is described.
4. Adjudication method for the test set:
- Not applicable as no specific test set or ground truth establishment is described.
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:
- Not applicable. This is a medical device for blood collection, not an AI or imaging diagnostic device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no specific ground truth for performance evaluation is described. The "ground truth" for the 510(k) submission is the existence and established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not a machine learning model.
Summary of the Study:
The "study" presented in this 510(k) summary is not a traditional performance study as one might expect for a novel device or an AI/software product. Instead, it is a comparative analysis for substantial equivalence against legally marketed predicate devices. The document outlines the characteristics of the SAFE-T-FILL® Capillary Blood Collection System and compares them to those of three predicate devices: StatSampler® (K896206), CapiJect® Capillary Blood Collection System (K833475), and Microtainer® Tube with EDTA and Microgard™ Closure (K931368).
The "proof" that the device meets "acceptance criteria" (which are implicitly defined by the characteristics and performance of the predicate devices) is demonstrated through this comparative table and the assertion that the new device shares similar characteristics and intended use with the existing, legally marketed devices. The FDA's letter states that they have reviewed the submission and determined the device is "substantially equivalent" to the predicate devices, thereby permitting it to be marketed.
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NOV 1 2 1998 O. Box 586, Needham, MA 02194 Phone: 800/535-6734 781/433-0766 Fax: 781/433-0767
510(k) SUMMARY
June 5, 1998
| Submitter: | RAM Scientific, Inc.P.O. Box 586Needham, Massachusetts 02194Phone (781) 433-0766Fax (781) 433-0767 |
|---|---|
| ------------ | -------------------------------------------------------------------------------------------------------------------- |
Contact Person: Monique Muri RAM Scientific, Inc. Phone (781) 433-0766 (781) 433-0767 Fax
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 Blood Collection System (K833475); and Microtainer® Tube with EDTA and Microgard™ Closure (K931368).
The SAFE-T-FILL® Capillary Blood Collection System is a Description: 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 different colors which identify the general type of additive or 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.
The SAFE-T-FILL® Capillary Blood Collection System is Intended Use: 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.
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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
11 million
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 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 image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 2 1998 Ram Scientific C/O Mr. Geoffrey M. Levitt Venable, Baetjer, Howard & Civiletti,LLP 1201 New York Avenue, N.W Suite 1000 Washington, DC 20005-3917
K983517 Re : SAFE-T-FILL® Capillary Blood Collection System Trade Name: Requlatory Class: II Product Code: JKA Dated: October 7, 1998 Received: October 7, 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, 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 requlatory 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 leqally 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. 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/dsma/dsmamain.html".
Sincerely yours,
Steven Toutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K983517 |
|---|---|
| --------------------------- | --------- |
Device Name:_
Indications For Use:
STATEMENT OF INDICATIONS FOR USAGE
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 testing.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical La
510(k) Number. K98 3517
Prescription Use_ (Per 21 CFR 801.109)
OR
(Optional Format 1-2-96)
Over-The-Counter Use_
§ 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.