FOR 7th Collections AND Ax بي جي جي هم INDICATED OF White -17-11-17 Blours SPECIMIANS Priva 70 FURTHER TESTING
The One Stick™ Volumeters™ and Y-Set families are indicated for the collection and handling of blood specimens prior to further testing.

Device Description

One Stick" Volumeters™ and Y-Set family of sets are supplied as sterile devices, and are intended for single patient use only. They are available in 3cc and 5cc sizes and are manufactured per cGMP Standards. The Y sets are comprised of standard components currently on the market. The Y sets are currently covered by 510(k) K051499. The barrel of the Volumeter™ is currently marketed by Becton Dickinson in their 3ml syringe. The Vent cap is molded with Class VI polypropylene, silicone O-ring and a Gore expanded PTFE supported membrane.
The One Stick™ Device is a blood collection assistance device for drawing samples from patients with suboptimal blood flow for standard procedures (Elderly and pediatric patients, those patients that may experience blood vessel collapse or excessive hemolysis when conventional Vacutainers are used directly). The device consists of a male luer fitting for attaching to a venipuncture, a section of tubing connecting the luer to a Y-Connector with a Roberts clamp for interrupting flow, two additional sections of tubing attached to needless access devices. This Y device is then attached to a vented volume collection tube.

AI/ML Overview

The provided text is a 510(k) summary for the "One Stick™ Y Extension Set and Volumeter™". It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed information requested regarding acceptance criteria, the specific study design to prove acceptance criteria were met, sample sizes, expert involvement, or AI-related aspects.

The document focuses on establishing substantial equivalence based on descriptive and technological characteristics, and mentions general "performance characteristics" and "laboratory testing and biocompatibility information" without providing specifics.

Therefore, I will extract the information that is present and clearly state when the requested information is not available in the provided text.

Acceptance Criteria and Device Performance Study

The provided 510(k) summary does not explicitly define specific acceptance criteria or present a table comparing them to reported device performance. Instead, it relies on the concept of substantial equivalence to a predicate device. The general statement about performance is: "The results of these test show that when the devices are built to specifications they all function as expected. Detailed results can be found in engineering reports dated July 13th and August 17th 2005."

This indicates that internal testing was conducted to ensure the device met its design specifications and functioned as intended. The "acceptance criteria" can be inferred to be related to functioning as expected according to these specifications, which would align with the performance of the predicate device (Medegen Medical Manufacturing Services 510(k) K051499).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from "functions as expected" and predicate equivalence)	Reported Device Performance (as stated in the summary)
Device built to specifications functions as expected	"when the devices are built to specifications they all function as expected."
Biological compatibility (biocompatibility information mentioned)	Biocompatibility information presented.
Meets minimum requirements for intended use	The information presented provides assurance that the One Stick Blood collection assistance device will meet the minimum requirements that are considered acceptable for its intended use.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided text. The document refers to "engineering reports dated July 13th and August 17th 2005" for detailed results, which would likely contain this information.
Data Provenance: Not explicitly stated. Given it's an in-house engineering report, it's likely internal (possibly laboratory or bench testing) data. It is not indicated whether it is retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. This information is typically relevant for studies involving subjective assessments (e.g., image interpretation). This document describes performance testing of a physical medical device.

4. Adjudication method for the test set

Not applicable/Not specified. Adjudication methods are typically used in studies with multiple expert readers/assessors. This document describes performance testing of a physical medical device.

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

No. This document describes a physical medical device (blood collection assistance device) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study and AI-related effect sizes are not relevant to this submission.

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

No. This document describes a physical medical device and not an algorithm.

7. The type of ground truth used

For this type of device, the "ground truth" would be established by engineering specifications and functional requirements (e.g., flow rates, sterility, material properties, structural integrity, absence of hemolysis or clotting under specific conditions) rather than expert consensus, pathology, or outcomes data in the typical sense. The testing would verify that the device meets these pre-defined specifications.

8. The sample size for the training set

Not applicable/Not specified. This device is not an AI/machine learning model, so there is no "training set" in that context. If referring to manufacturing process validation or component testing, the sample sizes would be detailed in the referenced engineering reports, but are not provided here.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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MAR 3 1 2006

One Stick 510(k) Application Section E

K060672 P.1 of 3

510(K) SUMMARY

FOI RELEASABLE

Pursuant to § 513(i)(3)(A) of the Food, Drug, and Cosmetic Act, One Stick is r ursuall to g 515(1)(2)(11) of the Peop, Stag, Stag, Stag,
required to submit with this Premarket Notification ". . adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." One Stick chooses to submit a summary of information respecting safety and effectiveness.

Classification Name:		Intravascular Administration Set andExtension Set(includes needle less access devices/systemsand blood flow regulators)
Common/Usual Name:		Intravascular Administration Set
Proprietary Name:		One Stick™ Y Extentsion Set and Volumeter™
Device Classification:		Class II
Name		Number	21 CFR Ref.
Intravascular Admin SetSubcutaneous, Intravascular		FPA	8 880.5440
Owner/Operator:	One Stick LLCP.O. Box 3575Lubbock, Texas 79452-3575(806) 842-3999
Contact Person:	Tracy Magee, Vice President

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DESCRIPTION OF DEVICE

INDICATIONS FOR USE

The One Stick™ Volumeters™ and Y-Set families are indicated for the collection and handling of blood specimens prior to further testing.

DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

The One Stick™ Device is a blood collection assistance device for drawing samples from patients with suboptimal blood flow for standard procedures (Elderly and pediatric patients, those patients that may experience blood vessel collapse or excessive hemolysis when conventional Vacutainers are used directly). The device consists of a male luer fitting for attaching to a venipuncture, a section of tubing connecting the luer to a Y-Connector with a Roberts clamp for interrupting flow, two additional sections of tubing attached to needless access devices. This Y device is then attached to a vented volume collection tube.

The Y set or device was approved under 510(k) K051499 to Medegen Medical Manufacturing Services. In our case these devices are being produced by Medegen for One Stick. The barrel of the Volumeter is produced by BD and is molded from their standard tooling.

PERFORMANCE CHARACTERISTICS

The results of these test show that when the devices are built to specifications they all function as expected. Detailed results can be found in engineering reports dated July 13th and August 17th 2005.

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One Stick 510(k) Application K464672 123 SF 3 510(K) A Section E

CONCLUSION

One Stick believes that the One Stick" Blood collection assistance device is substantially equivalent to the currently marketed Intravascular Administration Set by Medegen Medical Manufacturing Services 510(k) K051499. A comparison of the descriptive characteristics of these products demonstrate the One Stick Blood collection assistance device is equivalent in its indications for use, while being very similar in design and materials. In addition, One Stick has presented laboratory testing and biocompatibility information. The information presented provides assurance that the One Stick Blood collection assistance device will meet the minimum requirements that are considered acceptable for its intended use.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

MAR 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

One Stick Limited Liability Company C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, Limited Liability Company 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K060672

Trade/Device Name: One Stick™ Y Extension Set and Volumeter™ Regulation Number: 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: March 10, 2006 Received: March 14, 2006

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page-2 - Mr. Mark Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements mount that a regulations and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration r ou intine (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisms (21 cert forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirelates the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 1110 loter warket 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), 11 you desire t the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inter of Small Manufacturers, International 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/dsma/dsmamain.html

Sincerely yours,

C. Liu, Ph.D.

Chiu Lin, Ph.D. Director Division of Dental, Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Kφb
er Use

Indications for Use

510(k) Number (if known):

One Stick Tim YExtension Device Name:

Indications For Use:

FOR 7th Collections AND Ax بي جي جي هم INDICATED OF White -17-11-17 Blours SPECIMIANS Priva 70 FURTHER TESTING

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Ten Service General H. : C: Lichial :

K06672

Page 1 of

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.