(92 days)
Not Found
Not Found
No
The description focuses on mechanical safety features and standard medical device components, with no mention of AI or ML.
No
The device is used for accessing an implanted medication port for solution infusion and blood sampling, and for preventing accidental needle stick injuries, not for treating a disease or condition.
No
The device is described as an "intravascular administration set" used for "solution infusion and blood sampling," and "delivery of medication." While it can be used for "blood sampling," its primary functions are for administering substances and providing a safe access point, not for diagnosing conditions or diseases based on the sampled blood.
No
The device description clearly outlines a physical medical device consisting of a needle, tubing, and an antineedle stick protector. There is no mention of software as a component or the primary 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 accessing an implanted medication port for solution infusion and blood sampling. This is a procedure performed on the patient for therapeutic or diagnostic purposes, not a test performed on a sample of bodily fluid or tissue outside the body to diagnose a condition.
- Device Description: The device is described as an intravascular administration set with a needle and tubing for delivering medication and blood sampling. This aligns with a medical device used for direct patient care, not an IVD which would typically involve reagents, analyzers, or test kits for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting specific substances in bodily fluids, or providing diagnostic information based on laboratory testing.
Therefore, the Port Access Infusion Set with Antineedle Stick Protector is a medical device used for patient access and administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Port Access Infusion Set with Antineedle Stick Protector is a safety intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Port Access Infusion Set with Antineedle Stick Protector is sterile, single use device with a non-coring Huber needle (90 degree), non-DEHP polyvinyl chloride tubing with or without Y connector or a needleless access connector which incorporates an integral antineedle stick protector used to prevent accidental needlestick injuries.
The device is used for accessing an implanted medication port by puncturing the septum of the medication port and is used for the delivery of medication and for blood sampling. Fluid administration through the non-DEHP polyvinyl chloride fluid pathway of the port access infusion set are those generally used in hospitals and for delivery of chemotherapy. The device includes an integral antineedle stick device that when used prevent clinician's needle stick injuries.
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
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
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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. Also, Kawasumi Laboratories has conducted biocompatibility tests on the body fluid contacting material portions of the device and Kawasmi Laboratories believe that the results of these tests and the clinical evaluation show the device is suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Exel Int Secure Touch Safety Huber 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.
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EXHIBIT 42
JUN - 6 2006
510(K) SUMMARY
SUBMITTER 1.
U.S. AGENT:
KAWASUMI LABORATORIES, INC. 3-28-15 Minami-Ohi Shinagawa-Ku. Tokyo 140 Japan PHONE: 81-3-376-1151 FAX: 81-3-376-3235 CONTACT: Mr. Kuroiwa
KAWASUMI LABORATORIES AMERICA, INC 4723 Oak Fair Blvd. Tampa, FL 33610 PHONE: (813) 630-5554 (813) 630-5033 FAX: CONTACT: Mr. Jack Pavlo
- NAME OF DEVICE: Kawasumi Laboratories Port Access Infusion Set with Antineedle Stick Protector COMMON NAME: Port Access Infusion Set or Huber Needle Infusion Set PROPRIETARY NAME: K-Shield Port Access Infusion Set CLASSIFICATION: Class II, Codified at 21 CFR 880.5540. PRODUCT CODE NUMBER: FPA
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- PREDICATE DEVICE: Exel Int Secure Touch Safety Huber Infusion Set
-
- DESCRIPTION OF THE DEVICE: The Port Access Infusion Set with Antineedle Stick Protector is sterile, single use device with a non-coring Huber needle (90 degree), non-DEHP polyvinyl chloride tubing with or without Y connector or a needleless access connector which incorporates an integral antineedle stick protector used to prevent accidental needlestick injuries.
- The device is used for accessing an implanted medication port by puncturing the BASIC CONCEPT: septum of the medication port and is used for the delivery of medication and for blood sampling. Fluid administration through the non-DEHP polyvinyl chloride fluid pathway of the port access infusion set are those generally used in hospitals and for delivery of chemotherapy. The device includes an integral antineedle stick device that when used prevent clinician's needle stick injuries
- SIGNIFICANT PERFORMANCE CHARACTERISTICS: There are no new performance characteristics of this device compared to the substantially equivalent device marketed for sale in interstate commerce. Both deliver fluids to the vascular system through a non reactive material and provide an integral antineedle stick protector feature.
- The Port Access Infusion Set with Antineedle Stick Protector is routinely used to 5. INTENDED USE: access implanted medication ports for the delivery of medications. The device incorporates an integral antineedle stick protector used to prevent accidental needle stick injuries to the clinician.
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- TECHNOLOGICAL CHARACTERISTICS: There are no technological characteristics of this device to the substantially equivalent device from Kawasumi Laboratories being marketed for sale in interstate commerce.
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Image /page/1/Picture/0 description: The image shows the text "K0600580 page 2 of 2" written in cursive. The text appears to be handwritten, with a slightly uneven and flowing style. The numbers and letters are clearly legible, and the phrase "page 2 of 2" indicates that this is the second page of a two-page document.
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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. Also, Kawasumi Laboratories has conducted biocompatibility tests on the body fluid contacting material portions of the device and Kawasmi Laboratories believe that the results of these tests and the clinical evaluation show the device is suitable for its intended use.
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- CONCLUSIONS: The device meets all the biocompatibility and pyrogenicity test requirements. The Antineedle stick protector has successfully been clinically evaluated. Therefore, it is safe as the predicate device and performs as well as the predicate device
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2006
Kawasumi Laboratories, Incorporated C/O Mr. Jack Pavlo Authorized Representative Kawasumi Laboratories America, Incorporated 4723 Oak Fair Boulevard Tampa, Florida 33610
Re: K060580
Trade/Device Name: Kawasumi Laboratories Port Access Infusion Set with Antineedle Stick Protector Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 3, 2006 Received: March 8, 2006
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.
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.
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); 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.
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 vour 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 (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 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/industry/support/index.html.
Sincerely vours.
Cars
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
EXHIBIT 40
Indications for Use
510(k) Number (if known): K060580
Device Name: Kawasumi Laboratories Port Access Infusion Set with Antineedle Stick Protector Indications For Use:
The Port Access Infusion Set with Antineedle Stick Protector is a safety intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.
Prescription Use ×
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Antony V. min
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 of Andrest resiology, General Hospital, Jon Control, Lontal Devices
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