(248 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the infusion set, with no mention of AI or ML.
No.
The device is used to access an implanted medication port for infusion and sampling, not to treat a specific medical condition or disease.
No
The device is used for infusion and blood sampling, which are therapeutic and collection procedures, not diagnostic ones. While collecting blood can be part of diagnostic testing, the device itself performs the collection, not the diagnosis.
No
The device description clearly outlines physical components like a non-coring Huber needle, tubing, and an antineedle stick protector, indicating it is a hardware 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, blood sampling, and injecting contrast media. These are all procedures performed on the patient, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The description details the physical components and function of the infusion set, which is used for delivering substances into the body or withdrawing blood from the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample to provide diagnostic information about a patient's condition. IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to detect diseases, conditions, or infections.
Therefore, the K-Shield Port Access Infusion Set with High Pressure Tubing is a medical device used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The K-Shield Port Access Infusion Set with High Pressure Tubing is an 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 high pressure tubing allows for the injection of contrast media with a power injector to 300 psi into an implanted port indicated for use with a power injector. The device is supplied sterile, non-pyrogenic and for single use. 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 K-Shield Port Access Infusion Set with High Pressure Tubing is a sterile, single use device with a non-coring Huber needle (90 degree), non-DEHP polyvinyl chloride tubing with or without Y connector which incorporates an integral antineedle stick protector used to prevent accidental needlestick injuries. The set can withstand injection pressures to 300 psi for use with power injectors to inject contrast media into implanted ports designed for use with power injectors.
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
Flow rate 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 and contrast media. The device includes an integral antineedle stick device that when used prevent clinician's needle stick injuries.
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 high pressure tubing during use and assess the product's substantial equivalence to the listed predicate devices:
- ISO 8536-4: Pass
- ASTM D2240 -05: Pass
- ISO 594-2: 1998: Pass
- ISO 8536-4 : additional Pressure Testing: Pass
- ISO 8536-4: tubing elongation testing: Pass
- ISO 8536-4: Maximum tubing pressure: Pass
- ISTA (International Safe Transit Association) 2A Transportation Test 2008: Pass
- Kawasumi internal test to validate flow rate: Pass
- Kawasumi internal test to validate pinch clamp pressure: Pass
- ASTM F 1929 -98: Pass
- EN-868-5: Pass
- ASTM F 1608-00: Pass
Kawasumi Laboratories believe that the results of these tests show the device is suitable for its intended use.
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.
Kawasumi Laboratories Port Access Infusion Set with Antineedle Stick Protector (K060580), Bard Power Loc Safety Infusion Set (K060812)
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
K100720/52.
EXHIBIT 4
NOV 1 9 2010
510(K) SUMMARY June 21, 2010
1. SUBMITTER
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 FAX: (813) 630-5033 CONTACT: Mr. Jack Pavlo
U.S. AGENT:
- NAME OF DEVICE: Kawasumi Laboratories Port Access Infusion Set with High Pressure Tubing COMMON NAME: Port Access Infusion Set or Huber Needle Infusion Set PROPRIETARY NAME: K-Shield Port Access Infusion Set with High Pressure Tubing CLASSIFICATION: Class II, Codified at 21 CFR 880.5540. PRODUCT CODE NUMBER: FPA
- DESCRIPTION OF THE DEVICE: The K-Shield Port Access Infusion Set with High Pressure Tubing is a sterile, single use device with a non-coring Huber needle (90 degree), non-DEHP polyvinyl chloride tubing with or without Y connector which incorporates an integral antineedle stick protector used to prevent accidental needlestick injuries. The set can withstand injection pressures to 300 psi for use with power injectors to inject contrast media into implanted ports designed for use with power injectors.
-
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, blood sampling, and injection of solutions to 300 psi. 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 and contrast media. 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 devices 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. -
- INDICATIONS FOR USE: The K-Shield Port Access Infusion Set with High Pressure Tubing is an 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 high pressure tubing allows for the injection of contrast media with a power injector to 300 psi into an implanted port indicated for use with a power injector. The device is supplied sterile, non-pyrogenic and for single use. 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.
-
- TECHNOLOGICAL CHARACTERISTICS: The design and technological characteristics of the K-Shield Port Access Infusion Set with High Pressure Tubing are substantially equivalent to the identified predicate devices. The design technological characteristics of the K-Shield Port Access Infusion Set are identical to K060580 with the exception of the
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following: 1) tubing can withstand injection pressure to 300 psi, 2) the tubing is composed of less plasticizer making the tubing suitable for high pressure power injections to 300 psi, 3) the product uses an open-ended Y connector with cap replacing the needleless Y connector, and 4) the female luer connector is composed of a different material. The technological characteristics of being able to withstand high pressure is substantially equivalent to the Bard device (K060812). The other identified differences do not have a significant impact on the safety or effectiveness of the device nor do they adversely affect the performance characteristics or biocompatibility of the device.
- SUMMARY OF NON-CLINICAL TESTING DATA: The following testing was performed to determine the 7. safety and effective of the high pressure tubing during use and assess the product's substantial equivalence to the listed predicate devices:
| Test | Result |
|---|---|
| ISO 8536-4 | Pass |
| ASTM D2240 -05 | Pass |
| ISO 594-2: 1998 | Pass |
| ISO 8536-4 : additional Pressure Testing | Pass |
| ISO 8536-4: tubing elongation testing | Pass |
| ISO 8536-4: Maximum tubing pressure | Pass |
| ISTA (International Safe Transit Association) 2A | |
| Transportation Test 2008 | Pass |
| Kawasumi internal test to validate flow rate | Pass |
| Kawasumi internal test to validate pinch clamp | |
| pressure | Pass |
| ASTM F 1929 -98 | Pass |
| EN-868-5 | Pass |
| ASTM F 1608-00 | Pass |
-
- PERFORMANCE DATA: Kawasumi Laboratories believe that the results of these tests show the device is suitable for its intended use.
-
- CONCLUSIONS: The K-Shield Port Access Infusion Set with High Pressure Tubing is substantially equivalent to the identified predicate devices and performs as well as the predicate devices for their intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of three wavy lines that are stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Kawasumi Laboratories, Incorporated C/O Ms. Suzan Onel K & L Gates .LLP 1601 K Street N.W. Washington, District of Columbia 20006
NOV 19 2010
Re: K100720
Trade/Device Name: K-Shiels Port Access Infusion Set with High Pressure Tubing Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 10, 2010 Received: November 12, 2010
Dear Ms. Onel:
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.
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Page 2- Ms. Onel
Enclosure
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Jana R. Robertson
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
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Indications for Use Statement
510(k) Number (if
known):
Device
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Name: K-Shield Port Access Infusion Set with High Pressure Tubing
Indications for Use:
The K-Shield Port Access Infusion Set with High Pressure Tubing is an 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 high pressure tubing allows for the injection of contrast media with a power injector to 300 psi into an implanted port indicated for use with a power injector. The device is supplied sterile, non-pyrogenic and for single The port access infusion sets are designed with an integral antineedle stick protector that use. 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 ✓
(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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 11/17/10
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K100720
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