(17 days)
Not Found
No
The device description and performance studies focus on mechanical function and standard components, with no mention of AI or ML.
No
The device is described as a "blood collection assistance device for drawing samples," indicating its purpose is for diagnostic sample collection, not for treating a condition.
No
Explanation: The device is indicated for the "collection and handling of blood specimens prior to further testing," and not for directly diagnosing any condition.
No
The device description clearly outlines physical components such as sterile devices, tubing, connectors, clamps, and a vented volume collection tube, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the collection and handling of blood specimens prior to further testing." This describes a device used to obtain a sample, not to perform a diagnostic test on the sample.
- Device Description: The description details a blood collection assistance device designed to help draw blood, particularly from patients with difficult blood flow. It focuses on the physical components for collection and handling.
- No Mention of Diagnostic Testing: There is no mention of the device performing any analysis, measurement, or interpretation of the blood sample itself to diagnose a condition or provide information about a patient's health status.
- Predicate Device: The predicate device is an "Intravascular Administration Set," which is also a device used for handling fluids in the body, not for in vitro diagnostic testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is solely to facilitate the collection of the specimen.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Elderly and pediatric patients
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)
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.
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
§ 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.
0
MAR 3 1 2006
g
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 and
Extension Set
(includes needle less access devices/systems
and 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 Set
Subcutaneous, Intravascular | | FPA | 8 880.5440 |
| Owner/Operator: | One Stick LLC
P.O. Box 3575
Lubbock, Texas 79452-3575
(806) 842-3999 | | |
| Contact Person: | Tracy Magee, Vice President | | |
1
DESCRIPTION OF DEVICE
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.
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.
2
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.
3
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.
4
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
5
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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
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