(55 days)
Not Found
No
The device description focuses on mechanical features for needle stick prevention and does not mention any computational or learning-based components.
No
The device is described as a needle for fluid administration/withdrawal and a safety feature to prevent needlestick injuries, not for treating or diagnosing a disease or condition.
No
Explanation: The device is designed for the administration or withdrawal of fluids and to protect against needlestick injuries. It does not provide any diagnostic information or function.
No
The device description clearly outlines a physical needle with a mechanical safety feature, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration or withdrawal of fluids from implanted ports and to protect against needlestick injuries. This is a direct interaction with the patient's body for therapeutic or diagnostic fluid management, not for testing samples in vitro (outside the body).
- Device Description: The description details a needle with a safety feature. This is a physical device used for accessing a port within the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Reagents or test kits
The GRIPPER PLUS™ Needle is a medical device used for accessing implanted ports, which is a procedure performed in vivo (within the body). Its primary function is related to fluid management and safety during that procedure.
N/A
Intended Use / Indications for Use
The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.
Product codes
FPA, FMI
Device Description
The GRIPPER PLUS™ Needle is similar in design to the current GRIPPER® Needle, with the incorporation of a passive needle stick protection feature. The protection feature is made of a base and arm with a hinge on one end. As the needle is removed from a portal the hinge allows the needle to be pulled back and locked into the capture well in the base. There is an audible "click" when the needle is captured. The device is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission. The needle tip is fully protected after deployment of the needle stick protection feature and will not disengage with normal handling such that the needle tip becomes exposed.
The needle will be offered in various needle gauges and lengths, and with or without a slit-septum injection site cap.
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
Not Found
Summary of Performance Studies
Functional Testing: In-vitro testing and simulated use testing was conducted in accordance with the FDA "Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features," dated March 1995. Biocompatibility testing was conducted on the device components.
Clinical Studies: Clinical studies were not deemed necessary regarding the GRIPPER PLUS™ Needles due to their similarity in materials, design and function to the current GRIPPER® Needle and Huber Plus Safety Infusion Set. The device was evaluated by health care professionals during a simulated use test and was found to be acceptable for its intended use.
Key results: The results of the testing indicated that the GRIPPER PLUS™ Needles function according to specifications and the materials used in the device are biocompatible. Simulated use testing indicated that the device's protection feature successfully activated during all attempts. Therefore, this product is considered acceptable for human use.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 1 3 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
GRIPPER PLUSTM Needle
June 18, 2002
I. GENERAL INFORMATION
| Applicant's Name and Address: | Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa J. Stone
Manager, Regulatory Affairs |
| Common/Usual Name: | Administration Set |
| Proprietary Name: | GRIPPER PLUS™ Needle |
| Equivalence Device Comparison: | GRIPPER® Needle
(manufactured by Deltec, Inc.)
Huber Plus Safety Infusion Set
(manufactured by NowMedical) |
II. DEVICE DESCRIPTION
The GRIPPER PLUS™ Needle is similar in design to the current GRIPPER® Needle, with the incorporation of a passive needle stick protection feature. The protection feature is made of a base and arm with a hinge on one end. As the needle is removed from a portal the hinge allows the needle to be pulled back and locked into the capture well in the base. There is an audible "click" when the needle is captured. The device is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission. The needle tip is fully protected after deployment of the needle stick protection feature and will not disengage with normal handling such that the needle tip becomes exposed.
The needle will be offered in various needle gauges and lengths, and with or without a slit-septum injection site cap.
Ш. INTENDED USE OF THE DEVICE
The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.
1
DEVICE COMPARISON IV.
| | GRIPPER PLUSTM
Needle | Huber Plus Safety
Infusion Set | GRIPPER® Needle |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------|
| MANUFACTURER | Deltec, Inc. | NowMedical | Deltec, Inc. |
| INDICATIONS FOR
USE | The GRIPPER PLUSTM
Needle is indicated for
the administration into or
withdrawal of fluids from
implanted ports. It is
designed to help protect
against exposure to
bloodborne pathogens
caused by accidental
needlestick injuries. | To be used with
implanted vascular ports. | Intended for the
administration into or
withdrawal of fluids from
implanted ports. |
| NONCORING NEEDLE | YES | YES | YES |
| NEEDLE-STICK
PREVENTION
FEATURE | YES | YES | NO |
| NEEDLE GAUGES | 22
20
19 | 22
20
19 | 22
20
19 |
| NEEDLE LENGTHS
(inches) | 0.625
0.75
1.0
1.25 | 0.5
0.75
1.0
1.25
1.5 | 0.625
0.75
1.0
1.25 |
| NEEDLE MATERIAL | Stainless Steel | Stainless Steel | Stainless Steel |
| TUBING DIMENSIONS
(Nominal) | | | |
| I.D.
O.D.
Length | 0.047 in.
0.103 in.
8.0 in. | 0.046 in.
0.091 in.
9 in. | 0.047 in.
0.103 in.
8.0 in. |
| TUBING MATERIAL | PVC plasticized with
TOTM | PVC (non-DEHP) | PVC plasticized with
TOTM |
| AVAILABLE WITH OR
WITHOUT INJECTION
SITE | YES | YES | YES |
2
V. SUMMARY OF STUDIES
Functional Testing A.
In-vitro testing and simulated use testing was conducted in accordance with the FDA "Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features," dated March 1995.
Biocompatibility testing was conducted on the device components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the GRIPPER PLUSTM Needles due to their similarity in materials, design and function to the current GRIPPER® Needle and Huber Plus Safety Infusion Set. The device was evaluated by health care professionals during a simulated use test and was found to be acceptable for its intended use.
ﺰ Conclusion Drawn from the Studies
The results of the testing indicated that the GRIPPER PLUS™ Needles function according to specifications and the materials used in the device are biocompatible. Simulated use testing indicated that the device's protection feature successfully activated during all attempts. Therefore, this product is considered acceptable for human use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human figures or silhouettes, arranged in a row, with their heads slightly overlapping.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2002
Mr. Edward W. Numainville Vice President, RA/OA SIMS Deltec. Incorporated 1265 Grey Fox Road Saint Paul, Minnesota 55112
Re: K021999
Trade/Device Name: GRIPPER PLUSTM Needle Regulation Number: 880.5440 and 880.5570 Regulation Name: Intravascular Administration Set and Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FPA and FMI Dated: June 18, 2002 Received: June 19, 2002
Dear Ms. Numainville:
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.
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.
4
Page 2 - Mr. Numainville
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours.
JSAWintAronson for.
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Ko2,1999
510(k) Number (if known):
Device Name: GRIPPER PLUS™ Needle
Indications for Use:
"The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K021999
000038