SAFEPICO

K043143 · Radiometer Medical Aps · JKA · Apr 22, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043143
• Device Name: SAFEPICO
• Applicant: Radiometer Medical Aps
• Product Code: JKA · Clinical Chemistry
• Decision Date: Apr 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The safePICO Arterial Blood Sampler is a preheparinized, electrolyte balanced, arterial blood sampler for collection of arterial samples for pH, blood gas, oximetry, electrolyte, and 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 Story

Manual arterial blood sampler; collects 0.7-1.5 mL arterial blood. Features: graduated plastic barrel, plunger, dry electrolyte-balanced lithium/sodium heparin, internal magnetic steel ball for mixing, vented tip cap for air venting, optional needle shield. Used by clinicians for arterial puncture. Input: arterial blood; Output: blood sample in sealed, vented syringe. Sample processed on ABL800 FLEX or ABL900 FLEX analyzers. Needle shield provides sharps injury prevention; shield activation force tested to ensure irreversibility. Benefits: standardized sample collection, reduced needle stick risk, improved sample mixing, and integrated venting.

Clinical Evidence

Simulated-use study (n=52 healthcare providers, 501 tests) compared safePICO to predicate. Primary endpoint: needle stick injuries (0 injuries observed). Secondary endpoints: successful shield activation, tip cap retention, and ease of use. Bench testing confirmed equivalent analyte recovery (pH, pO2, pCO2, electrolytes, metabolites, hemoglobin, bilirubin) compared to predicate on ABL800 FLEX analyzers. Mechanical testing verified shield activation forces and vented tip cap pressure specifications.

Technological Characteristics

Pre-heparinized, electrolyte-balanced piston syringe. Materials: plastic barrel/plunger, magnetic steel ball. Sterilization: Ethylene oxide (ISO/CD 11135:2001, EN550:1994) to SAL 10^-6. Features: vented tip cap, optional needle shield, barcode label. Connectivity: barcode readable by ABL800 FLEX analyzer. Dimensions: various needle gauges (22G, 23G) and lengths (16mm, 25mm, 32mm).

Indications for Use

Indicated for collection of arterial blood samples for pH, blood gas, oximetry, electrolyte, and metabolite analysis in patients requiring arterial blood gas monitoring.

Regulatory Classification

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.

Predicate Devices

• PICO Arterial Blood Sampler (k962158)
• PRO-VENT with NEEDLE-PRO (k011925)

Submission Summary (Full Text)

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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: [phone] or [phone] (direct) Phone: [phone] 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 Cap<br>Y/N | Needle Cube<br>Y/N | Protective Shield<br>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 .

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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 [phone]. 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 [phone] or [phone] 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