The arterial blood sampling syringe is intended for sampling of arterial blood for the measurement of p02, pCO2, pH, CO-oximetry, electrolytes (Ca++, Na++, K+, Cl+, and Mg++), Total Magnesium, and the metabolites (Glucose and Lactate).

Device Description

A commercially available hypodermic needle is modified by dispensing sodium heparin into the hub and cannula and then drying the heparin. The total recoverable volume of the heparin is approximately 5 U.S.P. units. The needle is then attached to a Pro-Vent® or Pulsator® Arterial Blood Sampling Syringe, which contains approximately 25 U.S.P. units of Calcium Neutralized Dry Lithium Heparin. The device is packaged and sterilized by Ethylene Oxide.

AI/ML Overview

Here's an analysis of the provided text regarding the Pro-Vent® and Pulsator® Arterial Blood Sampling Syringes:

K981035: Acceptance Criteria and Study Details

Based on the provided 510(k) summary, the device's acceptance criteria and the study proving it meets these criteria are primarily based on demonstrating substantial equivalence to a previously cleared predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence: The proposed syringes with dual heparin (dry calcium neutralized lithium heparin in syringe, dried sodium heparin in needle) must perform equivalently to the predicate device (Arterial Blood Sampling syringes with Calcium Neutralized Dry Lithium Heparin) for arterial blood sampling.	A side-by-side comparison was conducted.
Analytical Equivalence: The measurements obtained from blood samples using the proposed syringes must be statistically indistinguishable from those obtained using the predicate device for parameters including: pO2, pCO2, pH, CO-oximetry, Ca++, Mg++, Na+, K+, Cl-, Total Magnesium, Glucose, and Lactate.	"The results of the measurements were compared. There was no statistical difference between the proposed syringes and the predicate device" for all specified measurements (pO2, pCO2, pH, CO-oximetry, Ca++, Mg++, Na+, K+, Cl-, Total Magnesium, Glucose, and Lactate). This implies that the proposed syringe maintained the accuracy and reliability of the measurements compared to the predicate.
Material Equivalence: The materials of the syringe and needle should be unchanged from the predicate.	"Materials of the syringe and needle are unchanged from our current Arterial Blood Gas Sampling Syringes."
Sterilization Equivalence: Sterilization methods should be the same as those employed for the predicate.	"Sterilization is by the same methods employed in our existing Arterial Blood Gas Sampling Syringes, as authorized by FDA in 510(k) K952516."
Safety and Effectiveness: Demonstrate the proposed device is safe and effective.	"The testing performed and comparison to the predicate device demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample size used for the side-by-side comparison test.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a medical device modification, it is highly likely the data was prospectively collected as part of a formal verification and validation study. The testing was conducted by the manufacturer, SIMS Portex Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for this non-clinical study. The "ground truth" for this device comparison is the established performance of the legally marketed predicate device as measured by standard laboratory analysis. The comparison itself aims to show that the new device yields results consistent with these established analytical methods.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. This type of non-clinical comparison study evaluating analytical performance would not typically involve human adjudication in the way medical imaging studies might. The "adjudication" is based on statistical comparison of laboratory measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is an arterial blood sampling syringe, and its performance is evaluated based on the analytical results of the blood sample, not on human interpretation of images or clinical findings. Therefore, an MRMC study is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

Yes, in essence, a standalone performance was done for the device itself. The "device performance" in this context is its ability to collect a blood sample and preserve its analytes such that standard laboratory analysis yields results statistically equivalent to those obtained with a predicate device. This is inherently a "standalone" evaluation of the syringe's function prior to external analytical measurement. There is no "algorithm" involved in the clinical use or intended function of the syringe.

7. The Type of Ground Truth Used

The ground truth relied upon the analytical performance of the legally marketed predicate device. The "truth" for this study is that the predicate device's performance characteristics (e.g., how well it preserves pO2 or pH values) are acceptable and that the new device yields comparable analytical results when measured by standard laboratory equipment. It's a comparison to an established and accepted device, rather than an independent "ground truth" like pathology or long-term outcomes.

8. The Sample Size for the Training Set

Not applicable. This submission describes a non-clinical comparison study for a physical medical device (a syringe), not an algorithm or AI model that requires a "training set." There is no mention of machine learning or AI in the document.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set mentioned or implied for an AI/algorithm, this question is not relevant to the provided document.

Summary

{0}------------------------------------------------

K981035

Image /page/0/Picture/1 description: The image shows the logo for Smiths Industries Medical Systems. The logo is divided into two parts. The left side of the logo has the letters "SIMS" in a bold, stylized font. The right side of the logo has the words "SMITHS INDUSTRIES" in a bold, sans-serif font, with the words "Medical Systems" in a smaller, serif font below.

J: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

APR 21 1998

510(K) SUMMARY:

COMPANY INFORMATION:

SIMS Portex Inc 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Timothy J. Talcott Manager, Regulatory Affairs

PREPARATION DATE OF SUMMARY:

March 13, 1998

TRADE NAME:

Pro-Vent® and Pulsator® Arterial Blood Sampling Syringes

COMMON NAME:

Arterial Blood Sampling Syringes

PRODUCT CLASS/CLASSIFICATION:

Class II, 75 GJE, 21 CFR 862.1675.

PREDICATE DEVICE(S):

Our Arterial Blood Sampling syringes with Calcium Neutralized Dry Lithium Heparin (K952516).

SIMS Portex Inc.

10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703

{1}------------------------------------------------

DESCRIPTION:

INDICATIONS FOR USE:

The arterial blood sampling syringe is intended for sampling of arterial blood for the measurement of p02, pCO2, pH, CO-oximetry, electrolytes (Ca++, Na+, K+, Cl+, and Mg++), Total Magnesium, and the metabolites (Glucose and Lactate).

TECHNICAL CHARACTERISTICS:

The proposed syringe with heparinized needle has dry calcium neutralized lithium heparin in the syringe and dried sodium heparin in the needle. Calcium Neutralized Dry Lithium Heparin is used in our Arterial Blood Gas Sampling Syringes, currently legally marketed (K952516). Sodium Heparin is used in our liquid filled Arterial Blood Gas Sampling Syringes, currently marketed (K952516). Materials of the svringe and needle are unchanged from our current Arterial Blood Gas Sampling Syringes. Sterilization is by the same methods employed in our existing Arterial Blood Gas Sampling Syringes, as authorized by FDA in 510(k) K952516.

NON-CLINICAL DATA:

The proposed syringes were tested in a side-by-side comparison to our current Arterial Blood Sampling Syringes with Calcium Neutralized Dry Lithium Heparin. The testing consisted of the sampling of arterial blood and the subsequent measurement of p02, pCO2, pH, CO-oximetry, Ca++, Mg++, Na+, K+, C1-, Total Magnesium, Glucose, and Lactate. The results of the measurements were compared. There was no statistical difference between the proposed syringes and the predicate device.

{2}------------------------------------------------

CONCLUSION:

The testing performed and comparison to the predicate device demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SIMS Portex Inc dba Concord/Portex

Timothy J. Ickes

Timothy J. Talcott Manager, Regulatory Affairs

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 1 1998

Timothy J. Talcott . Manager, Regulatory Affairs SIMS Portex Inc. 10 Bowman Drive P.O. Box 0724 Keene, New Hampshire 03431

K981035 Re : Pro-Vent® and Pulsator® Arterial Blood Sampling Syringes Regulatory Class: II Product Code: JKA Dated: March 13, 1998 Received: March 19, 1998

Dear Mr. Talcott:

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 reqistration, listing of devices, good manufacturing practice, labelinq, 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 Regulation (QS) for Medical Devices: General requlation (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 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{4}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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) 594-4588. 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/dsmamain.html".

Sincerely yours,
Steven Bitman

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

{5}------------------------------------------------

B: INTENDED USE OF DEVICE

PROPOSED INDICATIONS FOR USE:

Patricia Bernhart (for A. Montgomery)

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

prescription use. ✓

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.