(21 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and standard blood collection/infusion technology, with no mention of AI or ML.
No
The devices are for accessing peripheral veins for blood collection or solution infusion, with a primary focus on preventing needle stick injuries. They do not directly treat or cure a disease or condition.
No
Explanation: The device is intended for blood collection and solution infusion, not for diagnosing medical conditions. It is a tool for accessing veins, not for interpreting diagnostic information.
No
The device description clearly outlines physical components like needles, wings, tubing, and luer connectors, and the performance studies focus on the mechanical function of the antineedle stick protector. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "access of peripheral veins for blood collection" and "access of peripheral veins for solution infusion." This describes a device used for collecting a sample from the body or administering something into the body.
- Device Description: The description details a needle and wing assembly with tubing and connectors used for blood collection or solution infusion. It also mentions a safety feature to prevent needle sticks.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) to collect the specimen or administer treatment.
- Performance Studies: The performance studies focus on the mechanical aspects of the device (wing activation/deactivation, locking mechanism) and simulated clinical use for safety (preventing needle sticks). These are not the types of performance studies typically associated with IVD devices, which would evaluate the accuracy and reliability of the in vitro test results.
In summary, the device is a medical device used for accessing veins, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The K-Shield Small Vein Infusion Set with Antineedle Stick Protector is used to access a patient's vein for solution infusion. The device incorporates an integral, active antineedle stick protector. The K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector is used to access a patlent's vein for blood sampling. The device incorporates an integral, active antineedle stick protector
The K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector intended use is for the access of peripheral veins for blood collection. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.
The K-Shield Small Vein Infusion Set with Antineedle Stick Protector intended use is for the access of peripheral veins for solution infusion. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The K-Shield Small Vein Infusion Set with Antineedle Stick Protector and the K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector are sterile, single use devices commonly used to access a palient's veins for blood collection or solution infusion. Both devices are comprised of a needle and wing assembly with tubing and a female luer connector. The Multisample Luer Connector is used to transfer blood from the Winged Collection Set to a vacuum tube. Both devices incorporate an integral antineedle stick protector used to prevent accidental needlestick injuries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral veins
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)
The following testing was performed to determine the safety and effective of the Small Vein Infusion Set with Antineedle Stick Protector and the Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector and assess the product's substantial equivalence to the listed predicate devices:
| Test | Result |
|---|---|
| Kawasumi Internal Test: Wing Activation | PASS |
| Kawasumi Internal Test: Wing Deactivation | PASS |
| Kawasumi Internal Test: Defeat Locking Mechanism | PASS |
Kawasumi Laboratories performed a simulated use study to determine the safety and effectiveness of the Antineedle Stick Protector for use with winged needle sets. The study objectives were to identify possible antineedle stick protector design problems, and for directions for use and labeling deficiencies, and to gain information for designing a user training program to facilitate proper use of the antineedle stick protector in the clinical setting.
Results: The simulated use study was successful. No needle sticks occurred during the trial. Comments on the Questionnaires did not indicate any problems in using the proposed Kawasumi winged needle sets with antineedle stick protectors.
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
EXHIBIT 27
KID 2890
OCT 2 1 2010
SPECIAL 510(K): DEVICE MODIFICATION SUMMARY September 29, 2010
- SUBMITTER U.S. AGENT:
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. Yuasa
KAWASUMI LABORATORIES AMERICA, INC 4723 Oak Fair Blvd. Tampa, FL 33610 PHONE: (813) 630-5554 (813) 230-2033 FAX: CONTACT: Mr. Jack Pavlo
- NAME OF DEVICE: Kawasumi Laboratories Small Vein Infusion Set with Antineedle Stick Protector and Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector COMMON NAME: Winged Collection Set, Small Vein Set PROPRIETARY NAME: K-Shield Small Vein Infusion Set with Antineedle Stick Protector and
K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector [Note: K-Shield is a Registered Trademark for the Kawasumi brand of needle protection devices.] CLASSIFICATION: Class II, Codified at 21 CFR 880.5540. PRODUCT CODE NUMBER: FPA
-
- DESCRIPTION OF THE DEVICE: The K-Shield Small Vein Infusion Set with Antineedle Stick Protector and the K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector are sterile, single use devices commonly used to access a palient's veins for blood collection or solution infusion. Both devices are comprised of a needle and wing assembly with tubing and a female luer connector. The Multisample Luer Connector is used to transfer blood from the Winged Collection Set to a vacuum tube. Both devices incorporate an integral antineedle stick protector used to prevent accidental needlestick injuries.
-
- SIGNIFICANT PERFORMANCE CHARACTERISTICS: There are no new performance characteristics of this device compared to the substantially equivalent devices marketed for sale in interstate commerce. Both devices are used to access a patient's vein for blood collection or solution infusion and provide an integral antineedle stick protector feature.
-
- INDICATIONS FOR USE: The K-Shield Small Vein Infusion Set with Antineedle Stick Protector is used to access a patient's vein for solution infusion. The device incorporates an integral, active antineedle stick protector. The K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector is used to access a patlent's vein for blood sampling. The device incorporates an integral, active antineedle stick protector
- 7.TECHNOLOGICAL CHARACTERISTICS: The design and technological characteristics of the K-Shield Small Vein Infusion Set with Antineedie Stick Protector and the K-Shield Winged Collection Set with Multisample Luer Connector and Antineedle Stick Protectorg are substantially equivalent to the identified predicate devices. The design technological characteristics of the K-Shield devices are identical to K023917 with the exception of the modification to the antineedle stick protector design which is streamlined to remove the barrel wings and slits. This modification simplifies the needle removal process siteammed to remove inc ourrely or effectiveness of the devices performance for their intended use.
100
i i
1
- SUMMARY OF NON-CLINICAL TESTING DATA: The following testing was performed to 8. determine the safety and effective of the Small Vein Infusion Set with Antineedle Stick Protector and the Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector and assess the product's substantial equivalence to the listed predicate devices:
| Test | Result |
|---|---|
| Kawasumi Internal Test: Wing Activation | PASS |
| Kawasumi Internal Test: Wing Deactivation | PASS |
| Kawasumi Internal Test: Defeat Locking Mechanism | PASS |
-
- SIMULATED CLINICAL OBSERVATIONS: Kawasumi Laboratories performed a simulated use study to determine the safety and effectiveness of the Antineedle Stick Protector for use with winged needle sets. The study objectives were to identify possible antineedle stick protector design problems, and for directions for use and labeling deficiencies, and to gain information for designing a user training program to facilitate proper use of the antineedle stick protector in the clinical setting.
Results: The simulated use study was successful. No needle sticks occurred during the trial. Comments on the Questionnaires did not indicate any problems in using the proposed Kawasumi winged needle sets with antineedle stick protectors.
- SIMULATED CLINICAL OBSERVATIONS: Kawasumi Laboratories performed a simulated use study to determine the safety and effectiveness of the Antineedle Stick Protector for use with winged needle sets. The study objectives were to identify possible antineedle stick protector design problems, and for directions for use and labeling deficiencies, and to gain information for designing a user training program to facilitate proper use of the antineedle stick protector in the clinical setting.
-
- PERFORMANCE DATA: Kawasumi Laboratories belleve that the results of these tests show the device is suitable for its intended use.
-
The K-Shield Small Vein Infusion Set with Antineedle Stick Protector and the 11. CONCLUSIONS: Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector are substantially equivalent to the identified predicate devices and perform as well as the predicate devices Small Vein Infusion Set with Antineedle Stick Protector and the Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector for their intended use.
2
Image /page/2/Picture/0 description: The image shows a partial view of a document with the words "DEPARTMENT OF" visible. To the left of the text is a logo or emblem featuring a stylized design with curved lines. The text is in a simple, sans-serif font, and the overall impression is that of an official document or letterhead.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jack Pavlo Manager of Technical Affairs Kawasumi Laboratories America, Incorporated 4723 Oak Fair Boulevard Tampa, Florida 33610
OCT 2 1 2010
Re: K102890
Trade/Device Name: K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 29, 2010 Received: September 30, 2010
Dear Mr. Pavlo:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2- Mr. Pavlo ·
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
OCT 2 1 2010
510(k) Number (if known): K102890
Device Name: K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector
Indications For Use: The K-Shield Winged Collection Set with Multisample Luer
Adapter and Antineedle Stick Protector intended use is for the access of peripheral veins for blood collection. The antineedle stick protector is an integral, active safety device intended to minimize
accidental needle stick injuries when used to shield the needle.
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)
l C. A
10/15/10
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of __
510(k) Number: K102890
5
Indications for Use
OCT 2 1 2010
510(k) Number (if known): K102890
Device Name: K-Shield Small Vein Infusion Set with Antineedle Stick Protector
Indications For Use: The K-Shield Small Vein Infusion Set with Antineedle Stick
Protector intended use is for the access of peripheral veins for solution infusion. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.
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)
Rici C. Ch
10/15/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: K102890