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.

Device Description

The barrel and plunger of the safePICO are identical to the barrel and plunger of the PICO Arterial Blood Sampler manufactured by Radiometer Medical ApS and cleared under K962158, PICO Arterial Blood Sampler. 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 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 male connector of the sampler. Further, the safePICO may be delivered either with a conventional needle cube of PVC or with a new safePICO needle shield device in order to avoid accidental needle stick of a user.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the safePICO device, focusing on acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary from 2005, does not explicitly list quantitative acceptance criteria for the safePICO device in the typical format of a modern regulatory submission (e.g., "The device shall achieve a sensitivity of > X% with a specificity of > Y%").

Instead, the summary describes performance tests conducted and then states a qualitative conclusion regarding their results or equivalence to predicate devices. The "reported device performance" is largely described through these qualitative statements of equivalence or "no new issues."

Here's an attempt to extract related information, acknowledging the limitations of the original document:

Acceptance Criteria (Implied)	Reported Device Performance
Arterial Blood Sampler Performance (Overall)
- Equivalence to predicate PICO70 Arterial Blood Sampler	"a large comparison study has been performed between the safePICO Arterial Blood Sampler, a predicate device, the PICO70 Arterial Blood Sampler, both used on an ABL800 FLEX Analyzer. This study showed that the safePICO Arterial Blood Sampler is substantially equivalent to the predicate device, the PICO70 Arterial Blood Sampler." (Implies comparable performance in parameter values for pH, blood gas, oximetry, electrolyte, and blood metabolite analyses, and absence of air entrapment issues.)
- Equivalence to predicate PRO-VENT with Needle Pro	"a large Simulated Use Study has been 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 and the products are at least as safe and effective as the Pro-Vent with Needle Pro." (Implies comparable safety and effectiveness regarding needle stick prevention).
Specific Sampler Features:
- Air entrapment during sampling	"The results of the tests [including air entrapment] showed no new issues of safety and effectiveness." (Implies acceptable levels of air entrapment, comparable to predicate).
- Parameter values (pH, blood gas, oximetry, electrolytes, etc.)	"The results of the tests [including parameter values] showed no new issues of safety and effectiveness." (Implies parameter values obtained with safePICO were within acceptable clinical ranges and comparable to predicate, though no specific numerical range is provided).
Vented Tip Cap Performance:
- Maximum holding pressure	"The results of the tests showed no new issues of safety and effectiveness." (Implies that the tip cap can withstand expected pressures without failure).
- Ventilation capability	"The results of the tests showed no new issues of safety and effectiveness." (Implies proper ventilation when the tip cap is applied).
- Penetration of ABL800 FLEX inlet probe	"The results of the tests showed no new issues of safety and effectiveness." (Implies the tip cap allows proper and easy penetration by the analyzer probe).
- Friction of ABL800 FLEX inlet probe	"The results of the tests showed no new issues of safety and effectiveness." (Implies the friction of the probe upon penetration and withdrawal from the tip cap is within acceptable limits).
Needle Shield Device Performance:
- Initial activation force	"The results of the tests showed no new issues of safety and effectiveness." (Implies the force required to activate the shield is appropriate).
- Forward displacement force	"The results of the tests showed no new issues of safety and effectiveness." (Implies the shield provides effective protection against forward movement of the needle after activation).
- Shield lock force	"The results of the tests showed no new issues of safety and effectiveness." (Implies the shield locks securely once activated).
- Unlocking force	"The results of the tests showed no new issues of safety and effectiveness." (Implies the shield, once locked, requires an appropriate amount of force to unlock, preventing accidental unlocking, or if designed to be permanent, is difficult to unlock).
Sterility Assurance	"The safePICO is sterilized to a Sterility Assurance Level (SAL) of 10⁻⁶." (This is a specific, quantitative acceptance criterion, met by validation according to ISO/CD 11135:2001 and EN550:1994).

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

Test Set Sample Size: The document repeatedly uses the term "large comparison study" and "large Simulated Use Study" but does not provide any specific numerical sample sizes for either the comparison study (safePICO vs. PICO70) or the simulated use study (safePICO with Needle Shield vs. Pro-Vent with Needle Pro).
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter's address (Brønshøj, Denmark), it is likely the studies were conducted by Radiometer Medical ApS or its affiliates, possibly in Denmark or other European locations. The studies appear to be prospective as they are performance tests conducted on prototypes to support a 510(k) submission.

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

There is no mention of experts or radiologists being used to establish ground truth for this device. The safePICO is a blood collection device, not an imaging or diagnostic AI medical device where expert interpretation would typically be the ground truth. The "ground truth" (or reference standard) would have been the analytical results from the ABL800 FLEX Analyzer for the comparison study, and the physical performance/safety assessments (e.g., needle stick prevention) for the simulated use study.

4. Adjudication Method for the Test Set

Not applicable. Since no human expert interpretation is involved in establishing a "ground truth" for this type of medical device, there is no adjudication method 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. The safePICO is a physical blood sampler, not an AI system that assists human readers in interpreting medical data. Therefore, an MRMC study and analysis of AI assistance effect size are not relevant to this device.

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

Not applicable. This device is a physical product (blood sampler), not an algorithm. Therefore, "standalone performance" in the context of AI algorithms is not relevant.

7. The Type of Ground Truth Used

For the "large comparison study" (safePICO vs. PICO70): The ground truth would have been the analytical results (parameter values) obtained from the ABL800 FLEX Analyzer. This is essentially an instrument-based reference standard for blood gas, oximetry, electrolyte, and blood metabolite analyses. The comparison aimed to show that samples collected with safePICO yielded results that were "substantially equivalent" to those collected with the predicate.
For the "large Simulated Use Study" (safePICO with Needle Shield vs. Pro-Vent with Needle Pro): The ground truth revolved around safety and effectiveness metrics related to needle stick prevention. This implies objective measurements of activation forces, displacement forces, lock forces, and observations of successful needle encapsulation, likely against pre-defined engineering and safety specifications (though these specific numerical specs are not provided in the summary).

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve machine learning or AI, and therefore does not have a "training set" in the conventional sense. The "prototype" devices used for testing would be equivalent to the test set, and there's no mention of a separate set of data used for training an algorithm.

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

Not applicable, as there is no training set for this type of device.

Summary

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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.

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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 CapY/N	Needle CubeY/N	Protective ShieldY/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 .

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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).

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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).

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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

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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

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.