(93 days)
Not Found
Not Found
No
The description focuses on a mechanical safety device and does not mention any AI or ML components or functionalities.
No
The device is described as an "Antineedle Stick Protector" and its purpose is to "minimize accidental needle stick injuries when used to shield needles." It is a safety device rather than one designed to diagnose, treat, or prevent a disease or condition in a patient.
No
The device is described as a safety device intended to minimize accidental needle stick injuries during solution infusion or blood sampling, and for venous access. It does not perform any diagnostic function.
No
The device description explicitly states it is a "polymeric device" and describes its physical function of shielding a needle, indicating it is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for minimizing accidental needle stick injuries during solution infusion and blood sampling, and for peripheral venous access for administration or collection. It focuses on the physical act of accessing the vein and protecting against injury.
- Device Description: The description reinforces this by stating it's a polymeric device designed to shield the needle when removed from the patient.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens in vitro (outside the body) to obtain information about a physiological state, health, or disease. The device's function is purely mechanical and safety-related during the procedure.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose or monitor medical conditions. This device's purpose is to facilitate the collection or administration of substances and prevent injury, not to analyze the collected sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles for Kawasumi products manufactured with a wing and needle assembly for solution infusion and blood sampling.
The Small Vein Infusion Set with Antineedle Stick Protector is a single use, sterile device used for peripheral venous access for solution administration or blood collection. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.
The Winged Collection Set with Multi-Sample Luer Adapter and Antineedle Stick Protector is a single use, sterile, blood collection device used for peripheral venous access for blood sampling. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Antineedle Stick Protector is a polymeric device designed to be used integral with winged needle sets and shields the needle when the needle with hub and wing assembly is removed from the patient
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral venous
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)
Kawasumi Laboratories has conducted a successful simulated use study to determine the acceptability of this device for use to minimize accidental needlestick injuries. Kawasumi Laboratories believes the successful simulated use study shows the device is suitable for its intended use and is substantially equivalent to the predicate device.
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.
Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set Kawasumi Winged Collection Set w/ Multi-Sample Luer Adapter Kawasumi Small Vein Infusion Set
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
FEB 2 6 2003
EXHBIT 29
510(k) SUMMARY
1. Submitter
Kawasumi Laboratories, Inc. 3-28-15 Minami-Ohi Shinagawa-Ku, Tokyo 140 Japan Phone: 81-3-376-1151 81-3-376-3235 Fax: Contact: Mr. K. So
Authorized Contact
Kawasumi Laboratories America, Inc. 5905 C Hampton Oaks Parkway Tampa, Fl 33610 Phone: 813-630-5554 813-630-5033 Fax: Contact: Mr. Jack Pavlo
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- Name of Device: Winged Needle Sets with an Antineedle Stick Protector
Common Name: Needle stick protector
- Name of Device: Winged Needle Sets with an Antineedle Stick Protector
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- Predicate Device: Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set Kawasumi Winged Collection Set w/ Multi-Sample Luer Adapter Kawasumi Small Vein Infusion Set
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- Description of the Device: The Antineedle Stick Protector is a polymeric device designed to be used integral with winged needle sets and shields the needle when the needle with hub and wing assembly is removed from the patient
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- Intended Use: The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles for Kawasumi products manufactured with a wing and needle assembly for solution infusion and blood sampling.
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- Technological Characteristics: The Antineedle Stick Protector is substantially equivalent to the Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set, Kawasumi Winged Collection Set w/ Multi-Sample Luer Adapter, and Kawasumi Small Vein Infusion Sets. The antineedle stick protector is activated in a different manner than the BD Safety-Lok Blood Collection Set, but achieve the same results. In both devices, the needle tip is protected inside the device after use.
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- Performance Data: Kawasumi Laboratories has conducted a successful simulated use study to determine the acceptability of this device for use to minimize accidental needlestick injuries. Kawasumi Laboratories believes the successful simulated use study shows the device is suitable for its intended use and is substantially equivalent to the predicate device.
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- Conclusions: The device is as safe as the predicate device and performs as well as the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human figures, one behind the other, with their arms raised.
Public Health Service
FEB 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kawasumi Laboratories, Incorporated C/O Mr. Donald Stone Kirkpatrick & Lockhart LLP 1800 Massachusetts Avenue, N.W. Suite 200 Washington, DC 20036
Re: K023917
Trade/Device Name: Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector, Small Vein Infusion Set with Antineedle Stick Protector Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 12, 2003 Received: February 13, 2003
Dear Mr. Stone:
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 application (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 such 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.
2
Page 2 - Mr. Stone
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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), please contact the Office of Compliance at (301) 594-4618. 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 Division 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 vours.
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Exhibit 12
Indications for Use
510(k) Number: K023917
Device Name: Small Vein Infusion Set with Antineedle Stick Protector
- Indications for Use: The Small Vein Infusion Set with Antineedle Stick Protector is a single use, sterile device used for peripheral venous access for solution administration or blood collection. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.
Device Name: Winged Collection Set with Multi-Sample Luer Adapter and Antineedle Stick Protector
Indications for Use The Winged Collection Set with Multi-Sample Luer Adapter and Antineedle Stick Protector is a single use, sterile, blood collection device used for peripheral venous access for blood sampling. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.
Lucia Cucurati
510(k) Number: K023917