(84 days)
SIMS Pro-Vent® Arterial Blood Sampling Kit with Calcium Neutralized Dry Lithium Heparin., AVL Scientific Corporation's Microsampler Arterial Blood Gas Kit, 240µl and 500µl.
No
The 510(k) summary describes a mechanical blood sampling device and does not mention any AI or ML components or functionalities.
No
The device is intended for obtaining blood samples for diagnostic measurements, not for treating a condition.
Yes
The phrase "measurement of pH, pO2, pCO2, CO-oximetry, electrolytes (Ca++, Mg++, Na+. Cl-, K+) and the metabolites (Glucose and Lactate)" in the "Intended Use / Indications for Use" section indicates that the device is used to obtain information about the health status of a patient, which is a characteristic of a diagnostic device.
No
The device description clearly outlines physical components like a needle, tube, and heparin, indicating it is a hardware device for blood sampling.
Based on the provided information, the SIMS Pro-Vent® 250 (500) Plus is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for obtaining small volume samples of blood. While these samples are used for in vitro diagnostic testing (measurement of pH, pO2, pCO2, etc.), the device itself is a sampling device, not a device that performs the diagnostic test on the sample.
- Device Description: The description focuses on the physical components for blood collection (needle, tube, heparin). It does not describe any components or processes for analyzing the blood sample.
- Performance Studies: The performance studies compare the device's ability to obtain the sample (fill time, comparison of measurements after sampling) rather than its ability to perform a diagnostic test on the sample.
An IVD device is typically a device, instrument, or reagent intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. The SIMS Pro-Vent® 250 (500) Plus is a tool for collecting the specimen, which is then used with an IVD device for analysis.
N/A
Intended Use / Indications for Use
The SIMS Pro-Vent® 250 (500) Plus is intended for obtaining small volume samples of blood for the measurement of pH, pO2, pCO2, CO-oximetry, electrolytes (Ca++, Mg++, Na+. Cl-, K+) and the metabolites (Glucose and Lactate).
Product codes
75 GJE
Device Description
The SIMS Pro-Vent® 250 (500) Plus contains a precision small volume sampling device for obtaining an arterial blood sample. The device consists of a small gauge needle (25g) attached to a single cannula vented tube with a micro volume of 250ul or 500pl (.25 or .50cc). The SIMS Pro-Vent® 250 (500) Plus is ideal for obtaining blood samples from pediatric, neonatal and geriatric patients. Each device contains approximately 40 units of Calcium Neutralized Dry Lithium Heparin per ml. The 250pl device contains approximately 10 U.S.P. units of heparin and the 500ul device contains approximately 20 U.S.P. units of heparin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arterial blood
Indicated Patient Age Range
pediatric, neonatal and geriatric patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed device was compared to AVL Scientific Corporation's Microsampler Arterial Blood Gas Kit, 240ul and 500ul, for fill time since both devices rely on arterial pressure for obtaining the sample. The results demonstrate that the proposed device fills under lower pressure and in less time than the predicate device.
The proposed device was tested in a side-by-side comparison to the SIMS Pro-Vent® Arterial Blood Sampling Kit with Calcium Neutralized Dry Lithium Heparin. The testing consisted of the sampling of arterial blood and the subsequent measurement of pO2, pCO2, pH, Ca++, Na+, K+, Cl-, and Glucose. The results of the measurements were compared. There was no statistical difference between the proposed device and the predicate device. There was no drift in the measurement of CO-oximetry when compared to the baseline for the blood sampled.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SIMS Pro-Vent® Arterial Blood Sampling Kit with Calcium Neutralized Dry Lithium Heparin., AVL Scientific Corporation's Microsampler Arterial Blood Gas Kit, 240µl and 500µl.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Smiths Industries Medical Systems. The logo consists of two lines of text, with the first line reading "SMITHS INDUSTRIES" in bold, sans-serif font. The second line reads "Medical Systems" in a smaller, serif font. To the left of the text is a stylized graphic.
SIMS Inc.
15 Kit Street Keene, NH 0343 i Telephone: (603) 352-3812 Fax: (603) 352-3703
は
OCT
H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY
COMPANY INFORMATION
Smiths Industries Medical Systems, Inc. 15 Kit Street Keene, NH 03431 ph(603) 352-3812 FAX (603) 357-5038 Contact: Timothy J. Talcott Manager, Regulatory Affairs
PREPARATION DATE OF SUMMARY
July 26, 1996
TRADE NAME
SIMS Pro-Vent® 250 (500) Plus
COMMON NAME
Arterial Blood Sampling Kit
CLASSIFICATION NAME
Class II, 75 GJE, 21 CFR 862.1675
1
PREDICATE DEVICE
్రార్థ
SIMS Pro-Vent® Arterial Blood Sampling Kit with Calcium Neutralized Dry Lithium Heparin.
AVL Scientific Corporation's Microsampler Arterial Blood Gas Kit, 240µl and 500µl.
DESCRIPTION
The SIMS Pro-Vent® 250 (500) Plus contains a precision small volume sampling device for obtaining an arterial blood sample. The device consists of a small gauge needle (25g) attached to a single cannula vented tube with a micro volume of 250ul or 500pl (.25 or .50cc). The SIMS Pro-Vent® 250 (500) Plus is ideal for obtaining blood samples from pediatric, neonatal and geriatric patients. Each device contains approximately 40 units of Calcium Neutralized Dry Lithium Heparin per ml. The 250pl device contains approximately 10 U.S.P. units of heparin and the 500ul device contains approximately 20 U.S.P. units of heparin.
INDICATIONS FOR USE
The SIMS Pro-Vent® 250 (500) Plus is intended for obtaining small volume samples of blood for the measurement of pH, pO2, pCO2, CO-oximetry, electrolytes (Ca++, Mg++, Na+. Cl-, K+) and the metabolites (Glucose and Lactate).
TECHNOLOGICAL CHARACTERISTICS
The proposed device has a calcium neutralized lithium heparin. Calcium Neutralized Dry Lithium Heparin is used in our Arterial Blood Gas Sampling Syringes, currently legally marketed (K952516). The proposed device draws a blood sample dependent on the arterial pressure in a similar manner as AVL Scientific Corporation's Microsampler Arterial Blood Gas Kit, 240ul and 500ul. Sterilization is by the same methods employed in our existing Arterial Blood Gas Sampling Kit.
SUMMARY OF PERFORMANCE DATA
The proposed device was compared to AVL Scientific Corporation's Microsampler Arterial Blood Gas Kit, 240ul and 500ul, for fill time since both devices rely on arterial pressure for obtaining the sample. The results demonstrate that the proposed device fills under lower pressure and in less time than the predicate device.
2
SUMMARY OF NONCLINICAL AND CLINICAL TESTS
The proposed device was tested in a side-by-side comparison to the SIMS Pro-Vent® Arterial Blood Sampling Kit with Calcium Neutralized Dry Lithium Heparin. The testing consisted of the sampling of arterial blood and the subsequent measurement of pO2, pCO2, pH, Ca++, Na+, K+, Cl-, and Glucose. The results of the measurements were compared. There was no statistical difference between the proposed device and the predicate device. There was no drift in the measurement of CO-oximetry when compared to the baseline for the blood sampled.
CONCLUSION OF NONCLINICAL AND CLINICAL TESTS
The testing performed and comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices.
ADDITIONAL INFORMATION
None
Very truly yours,
Smiths Industries Medical Systems, Inc. dba Concord/Portex
Timothy J. Jakou
Timothy J. Talcott Manager, Regulatory Affairs