(67 days)
No
The device description and intended use focus on mechanical features (antineedle stick protector) and standard medical procedures (accessing veins/arteries for blood). There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The "Kawasumi Laboratory Blood Drawing Kit" is explicitly stated as "a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition." The "Kawasumi Laboratories Phlebotomy Set" also states its intended use is "to aid in the treatment of a disease or other condition."
No
The devices are intended for accessing veins/arteries, drawing blood, or for hemodialysis, which are therapeutic or access procedures, not diagnostic ones.
No
The device description clearly describes physical components like needles, wings, hubs, and a polymeric antineedle stick protector, indicating it is a hardware device.
Based on the provided information, none of these devices are IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. This testing is performed outside of the living body (in vitro).
- Intended Use of These Devices: The intended uses described for all three Kawasumi devices involve accessing a vein or artery to remove blood from the patient for therapeutic purposes (hemodialysis, treatment of a disease or condition). They are used as conduits for blood flow from the patient.
- Lack of In Vitro Testing: There is no mention of these devices being used to test or analyze the collected blood in vitro. Their function is solely related to the collection and transfer of blood from the patient.
Therefore, these devices are considered therapeutic devices used for blood collection from the patient, not devices used for in vitro diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
Name: Kawasumi A.V. Fistula Set
Intended Use: This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery.
Name: Kawasumi Laboratory Blood Drawing Kit
Intended Use: This is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. This device is not intended for blood transfusions. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.
Name: Kawasumi Laboratories Phlebotomy Set
Intended Use: This device is intended to be used to access a patient's vein and as a conduit for blood removal to a vacuum bottle to aid in the treatment of a disease or other condition. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injures when the device is activated during removal from the patient's vein.
Product codes
FMI
Device Description
The design of the three previously cleared to market 510(k) devices has not changed except to add the integral antineedle stick protector. The antineedle stick protector is a polymeric device designed to be used integral with the wing and needle 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
vein or artery
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)
Kawasuni 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)
Medisytems Mastergurd Arterial Venous Fistula Set (K932074), Kawasumi A.V. Fistula Set (K873421), Kawasumi Laboratory Blood Drawing Kit (K001043), and Kawasumi Laboratories Phlebotomy Set (K994323)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
EXHIBIT 33
510(k) SUMMARY
l. 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
Authorized Contact
Kawasumi Laboratories America, Inc. 5905 C Hampton Oaks Parkway Tampa, F1 33610 Phone: 813-630-5554 Fax: 813-630-5033 Contact: Mr. Jack Pavlo
్ర 3008
- Name of Device: Winged Needle Sets with an Antineedle Stick Protector
Three previously cleared to market 510(k) devices are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient.
-
- 510(k) Number: K873421, Name: Kawasumi A.V. Fistula Set
-
- 510(k) Number: K001043, Name: Kawasumi Laboratory Blood Drawing Kit
-
- 510(k) Number: K994323, Name: Kawasumi Laboratories Phlebotomy Set
-
- Description of the Device: The design of the three previously cleared to market 510(k) devices has not changed except to add the integral antineedle stick protector. The antineedle stick protector is a polymeric device designed to be used integral with the wing and needle and shields the needle when the needle with hub and wing assembly is removed from the patient
5. Intended Use:
-
- 510(k) Number: K873421
Name: Kawasumi A.V. Fistula Set
- 510(k) Number: K873421
Intended Use: This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery.
-
- 510(k) Number: K001043
Name: Kawasumi Laboratory Blood Drawing Kit
- 510(k) Number: K001043
Intended Use: This is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. This device is not intended for blood transfusions. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.
1
-
510(k0 Number: K994323 3.
Name: Kawasumi Laboratories Phlebotomy Set Intended Use: This device is intended to be used to access a patient's vein and as a conduit for blood removal to a vacuum bottle to aid in the treatment of a disease or other condition. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injures when the device is activated during removal from the patient's vein. -
6.Technological Characteristics: The Antineedle Stick Protector is substantially equivalent to the Medisystems Masterguard Sets. The antineedle stick protector is activated in a different manner than the Medisystems Masterguard Set, but achieves the same results. In both devices, the needle tip is protected inside the device after use.
-
- Performance Data: Kawasuni Laboratories has conducted a successful simulated use study to determine the acceptability of this device for use to minimize accidental needlestick Kawasumi Laboratories believes the successful simulated use study shows the injuries. device is suitable for its intended use and is substantially equivalent to the predicate device.
-
- Conclusions: The device is as safe as the predicate device and performs as well as the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
JAN 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kawasumi Laboratories, Incorporated C/O Mr. Jack Pavlo Authorized Representative Kawasumi Laboratories America, Incorporated 4723 Oak Fair Boulevard Tampa, Florida 33610
Re: K073257
Trade/Device Name: Kawasumi Laboratories Large Wing Scts with Antineedle Stick Protector Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 16, 2007 Received: November 23, 2007
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 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 (240) 276-0120. 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 yours,
Chiu-Ying, Ph.D.
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
Indications for Use
510(k) Number (if known): KD73257
Device Name:_Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector
Indications For Use:
Name: Kawasumi A.V. Fistula Set
Intended Use: This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery.
Name: Kawasumi Laboratory Blood Drawing Kit
Intended Use: This is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. This device is not intended for blood transfusions. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.
Name: Kawasumi Laboratories Phlebotomy Set
Intended Use: This device is intended to be used to access a patient's vein and as a conduit for blood removal to a vacuum bottle to aid in the treatment of a disease or other condition. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injures when the device is activated during removal from the patient's vein.
Prescription Use X (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)
(Division Sign )ff) Division of Anestnesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 上午了325个