(158 days)
Not Found
No
The document describes a physical medical device (arterial blood sampler) and its components. There is no mention of software, algorithms, or any technology that would typically involve AI or ML. The performance studies focus on the physical characteristics and function of the sampler.
No.
The device is described as an arterial blood sampler for collection of arterial samples for analysis, not for treating any condition or disease.
No.
The device is an arterial blood sampler used for collecting samples. While these samples are used for diagnostic analyses, the sampler itself does not perform any diagnostic function; it is a collection and pre-analytical device.
No
The device description clearly outlines physical components like a barrel, plunger, magnetic steel ball, barcode, vented tip cap, and potentially a needle shield device. These are all hardware components, not software.
Based on the provided information, the safePICO Arterial Blood Sampler is not an IVD (In Vitro Diagnostic) device itself, but it is a device used for collecting samples for IVD analysis.
Here's why:
- Intended Use: The intended use clearly states it's for the "collection of arterial samples for pH, blood gas, oximetry, electrolyte and blood metabolite analyses." These analyses are performed in vitro (outside the body) using other diagnostic devices (like the ABL800 FLEX Analyzer mentioned in the performance studies).
- Device Description: The description focuses on the physical components for sample collection (barrel, plunger, magnetic ball, barcode, tip cap, needle shield). It doesn't describe any components that perform the diagnostic analysis itself.
- Performance Studies: The performance studies evaluate the sampler's ability to collect and handle the sample effectively and safely (air entrapment, parameter values, holding pressure, ventilation, needle shield function). They also compare its performance in terms of sample collection and handling to predicate devices, not its ability to perform the diagnostic analysis.
- Predicate Devices: The predicate devices are also arterial blood samplers, not diagnostic analyzers.
In summary: The safePICO Arterial Blood Sampler is a sample collection device that is a crucial part of the process for performing in vitro diagnostic tests on arterial blood. It is not the diagnostic device itself.
N/A
Intended Use / Indications for Use
The safePICO Arterial Blood Sampler is a preheparinized, electrolyte balanced, arterial sampler for collection of arterial samples for pH, blood gas, oximetry, electrolyte and blood metabolite analyses. The safePICO is a vented sampler for sample volumes in the range from 0.7 to 1.5 mL. The safePICO includes a vented tip cap allowing the sampler to be vented after the appliance of the tip cap and may include a needle shield device to prevent a user from accidental needle stick.
Product codes (comma separated list FDA assigned to the subject device)
JKA, MEG
Device Description
The safePICO sampler is based on the barrel and plunger of the arterial blood sampler developed by Radiometer Medical ApS and cleared under K962158, PICO Arterial Blood Sampler.
New features:
In the sampler barrel the safePICO includes a soft magnetic steel ball for mixing the sample. On the outside of the sampler barrel the safePICO has a barcode for allowing independent identification of each sampler.
The safePICO sampler is delivered with a new vented tip cap that allows the sampler to be vented after the appliance of the tip cap to the sampler. Further, the safePICO may be delivered either with a conventional needle or with a new needle cube of PVC or with a new protective needle shield device in order to avoid accidental needle stick of a user.
Use of the steel ball, the unique barcode and the vented tip cap is particularly relevant when the safePICO sampler is used on a new ABL800 FLEX Analyzer (Subject of a separate 510(k) application, K043132). In the new inlet module, the barcode may be automatically read and the steel ball is used to automatically mix the sample prior to measurement. The sampler is vented via the vented tip cap.
The safePICO sample is provided in the following versions:
Code No. Needle Size Vented Tip Cap Y/N Needle Cube Y/N Protective Shield Y/N
956-610 - Y N N
956-611 22G x 32 mm Y Y N
956-612 23G x 16 mm Y Y N
956-613 22G x 25 mm Y Y N
956-614 22G x 32 mm Y N Y
956-615 23G x 16 mm Y N Y
956-616 22G x 25 mm Y N Y
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arterial samples
Indicated Patient Age Range
Not Found
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)
-
Performance test:
- Tests performed on the prototype of the safePICO sampler:
- Air entrapment
- Parameter values
- Tests performed on the prototype of the vented tip cap:
- Maximum holding pressure
- Ventilation
- Penetration of ABL800 FLEX inlet probe
- Friction of ABL800 FLEX inlet probe
- Tests performed on the prototype of the needle shield device:
- Initial activation force
- Forward displacement force
- Shield lock force
- Unlocking force
- The results of the tests showed no new issues of safety and effectiveness.
- Tests performed on the prototype of the safePICO sampler:
-
Comparison study: A large comparison study was performed between the safePICO Arterial Blood Sampler and the predicate device, the PICO70 Arterial Blood Sampler, both used on an ABL800 FLEX Analyzer. The study showed that the safePICO Arterial Blood Sampler is equivalent to the predicate device.
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Simulated Use Study: A large Simulated Use Study was performed on the safePICO with Needle Shield Device and the predicate device Pro-Vent with Needle Pro. This study showed that the safePICO with Needle Shield Device is at least as safe and effective as the Pro-Vent with Needle Pro.
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.
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
§ 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
510(k) Premarket Notification K043143; safePICO
RADIOMETER COPENHAGEN
APR 2 2 2005
March 18, 2005
510(k) Summary - safePICO
Page 1 of 3
Radiometer Medical ApS Submitter: Åkandevej 21, DK-2700 Brønshøj, Denmark Address: +45 3827 3827 or +45 3827 3390 (direct) Phone: +45 3827 2736 Fax: Ms. Kirsten Rønø Contact Person: Date Summary Prepared: March 18, 2005
| Trade Name: | safePICO |
|---|---|
| Common name: | Vented Arterial Blood Sampler |
| Classification Name: | Piston Syringe |
Predicate Devices
FTEGICSRC DOVIGOO
Device Description
Device Debornprise. The barrer and planger of the carer 10 of himner Medical ApS and cleared under K962158, PICO Arterial Blood Sampler.
New features
New reatures
In the sampler barrel the safePICO includes a soft magnetic steel ball for mixing the sample In the Sampler Damer the Safer 100 molado a conver has a barcode before measurement. On the outcide of the allowing independent identification of each sampler.
The safePICO sampler is delivered with a new vented tip cap that allows the sampler to be The Saler ICO Sampler is delivery with a now connector of the sampler. Further, the vented alter the appliance of the tip oap to the mars a needle cube of PVC or with a new salePICO may be delivered eliner with a conventional necessor in order to avoid accidental needle stick of a user.
Use of the steel ball, the unique barcode and the vented tip cap is paticularly relevant when Use of the steel ball, the unique baroode and the read on the ABL800 FLEX using the Safer ICO sampler in a now adtorination). In the new inlet module, the barcode allary.et (Subject of a separate o ro(t) application, and to automatically mix the sample prior to
may be automatically read and the steel ball is used to automatically mix t may be automatically read and the stock bailer in assumer wia the vented tip cap.
1
RADIOMETER COPENHAGEN
March 18, 2005
510(k) Summary - safePICO
Page 2 of 3
The safePICO sample is provided in the following versions:
| Code No. | Needle Size | Vented Tip Cap
Y/N | Needle Cube
Y/N | Protective Shield
Y/N |
|----------|-------------|-----------------------|--------------------|--------------------------|
| 956-610 | - | Y | N | N |
| 956-611 | 22G x 32 mm | Y | Y | N |
| 956-612 | 23G x 16 mm | Y | Y | N |
| 956-613 | 22G x 25 mm | Y | Y | N |
| 956-614 | 22G x 32 mm | Y | N | Y |
| 956-615 | 23G x 16 mm | Y | N | Y |
| 956-616 | 22G x 25 mm | Y | N | Y |
Intended Use
The safePICO Arterial Blood Sampler is a preheparinized, electrolyte balanced, arterial The Saler TOO Artonal Blood Campial samples for pH, blood gas, oximetry, electrolyte and blood ournpler for collection of DICO is a vented sampler for sample volumes in the range from 0.7 to 1.5 mL. The safePICO includes a vented tip cap allowing the sampler to be from v.r to the appliance of the tip cap and may include a needle shield device to prevent a user from accidental needle stick.
Performance test
The following tests were performed on the prototype of the safePICO sampler:
- . Air entrapment
- Parameter values .
The following tests were performed on the prototype of the vented tip cap:
- Maximum holding pressure .
- Ventilation .
- Penetration of ABL800 FLEX inlet probe .
- Friction of ABL800 FLEX inlet probe .
2
RADIOMETER COPENHAGEN
March 18, 2005
510(k) Summary - safePICO
Page 3 of 3
The following tests were performed on the prototype of the needle shield device:
- Initial activation force .
- Forward displacement force .
- Shield lock force .
- Unlocking force .
The results of the tests showed no new issues of safety and effectiveness.
Further, a large comparison study has been performed between the safePICO Arterial Blood r untiler, a large ochipancen enaby fles a a comment blood Sampler, both used on an Oampler and the products as trudy showed that the safePICO Arterial Blood Sampler ADE000 FEEX AnalyLent to the predicate device, the PICO70 Arterial Blood Sampler.
Finally, a large Simulated Use Study has been performed on the safePICO with Needle I maily, a large eimalate device Pro-Vent with Needle Pro. This study showed that Shield Device and the products as at least as safe and effective as the Pro-Vent with Needle Pro.
Additional Safety Information
Manufacturing controls include visual, functional and sterility tests.
The sterility of the device is assured using a sterilization method validated in accordance with:
ISO/CD 11135: 2001: Sterilization of health care products - Requirements of development, validation and routine control of a sterilization process for medical devices - Ethylene oxide.
EN550: 1994: Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization
The safePICO is sterilized to a Sterility Assurance Level (SAL) of 10° .
Conclusion
The safePICO sampler is substantially equivalent in features and characteristics to the The Saler TOO Bampler 16 Sampler (K962158) and PRO-VENT (K011925).
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes forming its body and a wavy line below. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 2 2005
Ms. Lene Meineche Marnæs Regulatory Affairs Radiometer Medical APS Åkandevej 21 Brønshøj, Denmark DK-2700
K043143 Re:
Trade/Device Name: safePICO Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, MEG Dated: March 18, 2005 Received: March 21, 2005
Dear Ms. Marnæs:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon of the device is substantially equivalent (for the indications felerenced above and nave acterimined by marketed predicate devices marketed in interstate for use stated in the enorosale) to regary the Medical Device Amendments, or to commerce prov to May 20, 1976, the enaordance with the provisions of the Federal Food, Drug, devices may nave been recuire approval of a premarket approval application (PMA). allu Cosinctic Pec (110c) that do not require to the general controls provisions of the Act. The r ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is elassified (300 a00 v) itrols. Existing major regulations affecting your device n may be subject it 3den additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 can be found in Title 21, oncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination cutts of the att Please be advised hat FDA s issumes of a busease complies with other requirements of the Act that TDA has made a decornmancia ana Journer Federal agencies. You must of ally it cleral statutes and regulations and limited to: registration and listing (21 Comply with an the Free Frequire Parts 801 and 809); and good manufacturing practice CFR Fart 807), labeling (21 CF 11 11 11 11 11 11 11 11 11 11 11 Part 820).
4
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to organ mating of substantial equivalence of your device to a legally premarket notification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you destions on the promotion and advertising of your device, please contact the Office of In or quostions on the promie Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may oount outer generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sean M. Cooper, MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Premarket Notification K043143; safePICO
RADIOMETER COPENHAGEN
March 18, 2005
Indications for Use
K043143 510(k) Number:
safePICO Device Name:
Indications For Use:
The safePICO Arterial Blood Sampler is a preheparinized, electrolyte balanced, arterial The safePICO Artenal Biood Samples for pH, blood gas, oximetry, electrolyte and blood sampler for collection of artenal samples for samples volumes in the range metabolite analyses. The safePICO includes a vented tip cap allowing the sampler to be from 0.7 to 1.5 mL. The saferioo includes a ventou tip cap and may include a needle shield device to prevent a user from accidental needle stick.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Division Sign-Off
Page 1 of 1
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k) K043143