(134 days)
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Not Found
No
The description focuses on mechanical components and fluid dynamics for blood sampling, with no mention of AI/ML terms or functions.
No.
The device is designed for blood sampling and pressure monitoring, not for treating a disease or condition.
No
The device is designed for needle-free access of arterial blood for sampling and pressure monitoring, not for diagnosing a medical condition.
No
The device description clearly outlines multiple physical components including a stopcock, septum, syringe, tubing, and a plastic support. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "closed, needle-free access of arterial blood from pressure monitoring catheters" and "needle-free access of undiluted blood from arterial catheters". This describes a device used to obtain a blood sample, not to test or analyze the blood sample itself.
- Device Description: The components described (stopcock, septum, syringe, tubing, adapter) are all related to the mechanics of drawing blood and managing the fluid pathway. There are no components or descriptions related to performing a diagnostic test on the blood.
- Performance Studies: The performance studies focus on the physical properties of the device (tensile strength, leakage, frequency response) and its ability to safely and effectively obtain a blood sample. There are no studies related to the accuracy or performance of a diagnostic test.
- Key Metrics: There are no key metrics related to diagnostic performance (like sensitivity, specificity, etc.).
- Predicate Devices: The predicate devices are also related to blood sampling and pressure monitoring, not in vitro diagnostic testing.
In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate the collection of the specimen, not the analysis of it.
N/A
Intended Use / Indications for Use
The BIOPORT System is designed for closed, needle-free access of arterial blood from pressure monitoring catheters.
The BIOPORT System is designed for needle-free access of undiluted blood from arterial catheters (typically 16 or 18 Ga.) not longer than 6.4 cm (2 - ½ "). Diluted, heparinized blood is drawn beyond the BIOPORT into the BPS Reservoir Syringe to permit needle-free withdrawal of undiluted blood from the BIOPORT using a blood sampling syringe fitted with the Blunt Cannula Adapter (BPN). After the un-diluted sample is drawn, the heparinized, diluted blood in the Reservoir Syringe is reinfused into the patient to reduce fluid loss.
Product codes (comma separated list FDA assigned to the subject device)
DRS
Device Description
The BIOPORT System is composed of a 3-way stopcock; BIOPORT (a pre-slit latex rubber septum housed in a clear, rigid, plastic housing); a 3 cc Reservoir Syringe with protective dust cover over the plunger shaft to minimize contamination of Syringe contents by dust particles; and high-pressure Extension Tubing. The BIOPORT and stopcock are bonded 12 and 14 inches, respectively, from the distal male Luer lock connector of the pressure monitoring tubing. The 3-cc Luer lock Reservoir Syringe is pre-attached to the 3-way stopcock. The stopcock, BIOPORT, and Reservoir Syringe are located on a rigid plastic support equipped with a Velcro-type fastener for mounting on a patient's arm.
A Blunt Cannula Adapter (BPN)- terminating in a female Luer lock connector at one end for attachment to the male Luer of a sampling syringe, and a hollow, blunt plastic cone at the other end for insertion into the pre-slit septum of the BIOPORT- is provided separately to effect needle-free blood access via the BIOPORT.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Arterial blood from pressure monitoring catheters.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All components meet ISO 10993 and FDA’s G95-1 Memorandum biocompatibility requirements.
Performance data demonstrate that the tensile strength and resistance to leakage under pressure of the BIOPORT System components (all components bonded to tubing and the tubing itself) meet or exceed the requirements listed in International Standard ISO 8536-4 Infusion equipment for medical use- Part 4: Infusion sets for single use. This document is now accepted by the FDA as a Consensus Standard.
The frequency response (bandwidth) of the BIOTRANS Reusable Sensor Base with the BIOPORT sampling site present in the fluid pathway was evaluated in accordance with BP 22, American National Standard for Blood Pressure Transducers. The bandwidth was found to be acceptable (>200 Hz).
Tests of the Reservoir Syringes at hydrostatic pressures anticipated in the use of the device demonstrate the adequacy of the stop at the rear of the syringe barrel to minimize the potential for inadvertent expulsion of the plunger.
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.
Utah Medical Products Inc.'s ABC Pressure Monitoring Kits; Baxter Healthcare Corporation's VAMP Venous/Arterial Blood Management Protection; Migada Blunt Cannula.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).
0
Biosensors International's BIOPORT™ Closed Blood Sampling System Premarket Notification
9/21/98
510k SUMMARY
10 of 21
510k SUMMARY
FEB 5 1999 BIOPORT Closed Blood Sampling System Prepared August 21, 1998
1. Submitted by
John Shulze Sunscope International, Inc. 20250 Acacia St., Suite 115 Newport Beach, CA 92660 Tel: (949) 553-8300 Fax: (949) 553-9129
2. Contact Person
John Shulze
3. Device Identification
Trade Name Common Name Classification Name BIOPORT System Arterial Blood Access System Continuous Flush Catheter
4. Predicate Device(s)
Utah Medical Products Inc.'s ABC Pressure Monitoring Kits; Baxter Healthcare Corporation's VAMP Venous/Arterial Blood Management Protection; Migada Blunt Cannula.
5. Device Description
The BIOPORT System is composed of a 3-way stopcock; BIOPORT (a pre-slit latex rubber septum housed in a clear, rigid, plastic housing); a 3 cc Reservoir Syringe with protective dust cover over the plunger shaft to minimize contamination of Syringe contents by dust particles; and high-pressure Extension Tubing. The BIOPORT and stopcock are bonded 12 and 14 inches, respectively, from the distal male Luer lock connector of the pressure monitoring tubing. The 3-cc Luer lock Reservoir Syringe is pre-attached to the 3-way stopcock. The stopcock, BIOPORT, and Reservoir Syringe are located on a rigid plastic support equipped with a Velcro-type fastener for mounting on a patient's arm.
A Blunt Cannula Adapter (BPN)- terminating in a female Luer lock connector at one end for attachment to the male Luer of a sampling syringe, and a hollow, blunt plastic cone at the other end for insertion into the pre-slit septum of the BIOPORT- is provided separately to effect needle-free blood access via the BIOPORT.
6. Intended Use
BIOPORT Systems are designed for closed, needle-free access of arterial blood from pressure monitoring catheters.
The BIOPORT System is designed for needle-free access of undiluted blood from arterial catheters not longer than 6.4 cm (2 - ½ "). Diluted, heparinized blood is drawn beyond the BIOPORT into the BPS Reservoir Syringe to permit needle-free withdrawal of undiluted blood from the BIOPORT using a sampling syringe fitted with the Blunt Cannula Adapter (BPN). After the undiluted sample is drawn, the diluted, heparinized blood in the Reservoir Syringe is reinfused into the patient to reduce fluid loss.
1
Biosensors International's BIOPORT™ Closed Blood Sampling System Premarket Notification
9/21/98
11 of 21
7. Summary of Technological Characteristics of Device in relation to Predicate Device(s)
The configuration of the BIOPORT System with attached Reservoir Syringe is similar to that of the predicate arm-mounted VAMP (K885281). Heparinized, diluted blood is drawn into the VAMP reservoir to dear the BIOPORT and distal volume in the VAMP. It is drawn into BIOPORT's Reservoir Syringe to clear heparinized, diluted blood from the BIOPORT and volume distal to the BIOPORT in the BIOPORT System. In both systems the heparinized, diluted blood is returned to the patient.
8. Assessment of Performance Data used to justify Substantial Equivalence Claim
All components meet ISO 10993 and FDA's G95-1 Memorandum biocompatibility requirements.
Performance data demonstrate that the tensile strength and resistance to leakage under pressure of the BIOPORT System components (all components bonded to tubing and the tubing itself) meet or exceed the requirements listed in International Standard ISO 8536-4 Infusion equipment for medical use- Part 4: Infusion sets for single use. This document is now accepted by the FDA as a Consensus Standard.
The frequency response (bandwidth) of the BIOTRANS Reusable Sensor Base with the BIOPORT sampling site present in the fluid pathway was evaluated in accordance with BP 22, American National Standard for Blood Pressure Transducers. The bandwidth was found to be acceptable (>200 Hz).
The identical BIOPORT access site and Blunt Cannula Adapter are used in the predicate Utah Medical Products' ABC and have been cleared for identical purposes.
Tests of the Reservoir Syringes at hydrostatic pressures anticipated in the use of the device demonstrate the adequacy of the stop at the rear of the svringe barrel to minimize the potential for inadvertent expulsion of the plunger.
9. Conclusion
Data gathered by Biosensors indicate that the performance of Biosensors BIOPORT System is equivalent to that of the predicate devices or meets the requirements of applicable, published, well-accepted standards.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB
Phil Triolo, Ph.D. Principal C/O PT Consulting Sunscope International, Inc. 148 So. 1200 East 84102 Salt Lake City, UT
Re: K983372 Trade Name: BIOPORT System Requlatory Class: II Product Code: DRS December 21, 1998 Dated: Received: December 22, 1998
Dear Dr. Triolo:
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 A substantially equivalent determination assumes compliance with 895. 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket
3
Page 2 - Dr. Phil Triolo
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.
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) 594-4586. 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" (21CFR 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510 (k) Number (if known) K 983372
Device Name Biosensors Internationals' BIOPORT Closed Blood Sampling System
Indications for Use
The BIOPORT System is designed for closed, needle-free access of arterial blood from pressure monitoring catheters.
The BIOPORT System is designed for needle-free access of undiluted blood from arterial catheters (typically 16 or 18 Ga.) not longer than 6.4 cm (2 - ½ "). Diluted, heparinized blood is drawn beyond the BIOPORT into the BPS Reservoir Syringe to permit needle-free withdrawal of undiluted blood from the BIOPORT using a blood sampling syringe fitted with the Blunt Cannula Adapter (BPN). After the undijuted sample is drawn, the heparinized, diluted blood in the Reservoir Syringe is reinfused into the patient to reduce fluid loss.
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE, IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation | |||
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of Cardiovascular, Respiratory, | |||
| and Neurological Devices | |||
| 510(k) Number | K983372 | ||
| Prescription Use | OR | Over-the Counter Use | |
| (Per 21 CFR 801.109) | (Optional Format 1- |
(Optional Format 1-2-96)