(98 days)
This product is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against accidental needlestick injuries.
The GRIPPER® Micro needle is comprised of the inserter and the infusion site with extension tubing and a standard luer fitting; there are versions either with or without needless access connector y-site. The inserter incorporates a sharp trocar needle and retractor arm. The infusion site incorporates a small septum and an attached blunt cannula. When fully assembled, the inserter and infusion site are combined with the trocar needle inserted through the septum and blunt cannula. After insertion of the cannula and trocar into the implanted port, the inserter retractor arm is activated removing the trocar needle from the cannula and infusion site septum leaving the blunt cannula in the implanted port. The trocar needle tip is captured in the inserter to prevent needle stick injury, and the inserter is discarded. Upon removal of the infusion site from the implanted port, the blunt cannula is designed to further prevent needle stick injury that may result from rebounding action during infusion site extraction.
The provided text describes the GRIPPER® Micro 1.25 Inch Needle, which is an intravascular administration set designed to administer or withdraw fluids from implanted ports while preventing accidental needlestick injuries.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Testing: | Non-Clinical Testing: |
| Device meets specifications of predicate device. | The GRIPPER Micro 1.25 inch products meet the same specifications as set for the predicate device. |
| Force to attach and detach connections. | Tested (details of specific force values not provided). |
| Force to activate and deactivate safety features. | Tested (details of specific force values not provided). |
| Rate of fluid flow simulating extremes of pressure. | Tested (details of specific rate/pressure values not provided). |
| Strength of joints and bonds. | Tested (details of specific strength values not provided). |
| Biocompatibility. | Biocompatibility was established based on the similarity of materials of construction to the predicate devices. |
| Clinical/Simulated Use Testing: | Clinical/Simulated Use Testing: |
| Successful capture of the trocar tip in the capture zone upon activation of sharps protection. | All 500 activations (simulated use) resulted in successful captures of the trocar tip in the capture zone. (100% success rate reported). This indicates the device successfully prevents needlestick injuries as designed. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 500 activations.
- Data Provenance: The study was a "Simulated Use Study" conducted in accordance with FDA Guidance. This implies a prospective study involving human participants in a controlled, simulated environment, rather than retrospective real-world data. The country of origin for the data is not explicitly stated, but given the FDA guidance and the submitter's address in St. Paul, MN, it is highly probable the study was conducted in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The text does not specify a number of "experts" used to establish ground truth in the traditional sense of diagnostic assessment.
- Instead, the "ground truth" for the simulated use study was the successful capture of the trocar tip in the capture zone. This is an objective, binary outcome.
- The participants in the study were "Health care professionals... experienced in accessing and de-accessing implantable portals." Their role was to perform the simulated activities, not to adjudicate or establish a diagnostic ground truth.
4. Adjudication method for the test set
- There was no explicit adjudication method described in the text for the simulated use study.
- The outcome (successful capture of the trocar tip) appears to be an objective, directly observable event rather than one requiring expert interpretation or consensus. It likely involved a pass/fail assessment recorded for each activation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is a medical needle, not a diagnostic imaging AI system. The study focused on the physical performance and safety features of the device during simulated use, not on human interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical medical device. The "simulated use study" involved human healthcare professionals interacting with the device to evaluate its performance and safety features.
7. The type of ground truth used
- For the simulated use study, the ground truth was objective device performance: successful capture of the trocar tip in the capture zone. This is a direct outcome measure of the safety feature's functionality.
8. The sample size for the training set
- The concept of a "training set" is not applicable to this device or its evaluation. This is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable (as explained in point 8).
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Klollso.
心
TAB 6
AUG. 3 - 2010
510(k) Summary
GRIPPER® Micro 1.25 Inch Needle
Traditional 510(k) - GRIPPER Micro 1.25 Smiths Medical ASD, Inc.
Confidential
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smiths medical
bringing technology to life
510(k) Number:____
Page 1 of 3
April 23, 2010 Updated June 28, 2010 Date Prepared
Submitter Information
| Submitter's Name: | Smiths Medical ASD, Inc. |
|---|---|
| Address: | 1265 Grey Fox RoadSt. Paul, MN 55112 |
Establishment Registration: 2183502
| Contact Person: | Rachelle Parsons, RACSr. Regulatory Affairs Specialist |
|---|---|
| Phone:Fax: | (651) 628-7018(651) 628-7457 |
Device Information
| Trade Name: | GRIPPER® Micro Blunt Cannula, Non-Coring Safety Needle; 1.25 inch |
|---|---|
| Common Name: | GRIPPER® Micro Needle |
| Classification Name: | Intravascular Administration Set |
| Product Code: | FPA |
| Regulation: | 21 CFR §880.5440 |
Predicate Device(s)
The predicate devices are the currently marketed GRIPPER Micro Needles. The reference 510(k) number for these devices:
| Device | 510(k) |
|---|---|
| GRIPPER® Micro Blunt Cannula, Non-Coring Safety Needle | K072059 |
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smiths medical
bringing technology to life
Page 2 of 3
Device Description
The GRIPPER® Micro needle is comprised of the inserter and the infusion site with extension tubing and a standard luer fitting; there are versions either with or without needless access connector y-site. The inserter incorporates a sharp trocar needle and retractor arm. The infusion site incorporates a small septum and an attached blunt cannula. When fully assembled, the inserter and infusion site are combined with the trocar needle inserted through the septum and blunt cannula. After insertion of the cannula and trocar into the implanted port, the inserter retractor arm is activated removing the trocar needle from the cannula and infusion site septum leaving the blunt cannula in the implanted port. The trocar needle tip is captured in the inserter to prevent needle stick injury, and the inserter is discarded. Upon removal of the infusion site from the implanted port, the blunt cannula is designed to further prevent needle stick injury that may result from rebounding action during infusion site extraction.
Intended Use
The GRIPPER® Micro needle is designed for the administration into or withdrawal of fluids from implanted ports.
Indications for Use
The GRIPPER® Micro needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against accidental needlestick injuries.
Summary of Non-Clinical Testing
The non-clinical testing included assessment of the physical properties of the GRIPPER® Micro 1.25 inch needle and its ability to achieve its intended use. The GRIPPER Micro 1.25 inch products meet the same specifications as set for the predicate device. Testing performed based on FDA Guidance: Guidance for Industry and FDA Staff - Medical Devices with Sharps Iniurv Prevention Features. August 2005 included force to attach and detach connections, force to activate and deactivate the safety features, rate of fluid flow simulating extremes of pressure and strength of joints and bonds. The Bench testing of the device confirmed the suitability of the device for its intended use.
Biocompatibility assessment of the device was performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible based on the similarity of the materials of construction to the predicate devices commercially marketed by Smiths Medical ASD, Inc.
Traditional 510(k) -- GRIPPER Micro 1.25 Smiths Medical ASD, Inc.
Confidential
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smiths medical
bringing technology to life
Page 3 of 3
Summary of Clinical Testing
Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the GRIPPER® Micro Needle. A Simulated Use Study was condicted according to the FDA Guidance: Guidance for Industry and FDA Staff - Medical Devices with Sharps Injury Prevention Features, August 2005. Health care professionals were selected to participate in the simulated use evaluation from a cross section of users or potential users of the device. These participants were experienced in accessing and de-accessing implantable portals.
The purpose of the study was to simulate actual clinical use of the GRIPPER Micro Needle System 1.25 inch by health care professionals, in terms of installation, activation of sharps protection and deaccess of the infusion site. The sample size was based on the statistical rationale noted in the FDA guidance. All 500 activations resulted in successful captures of the trocar tip in the capture zone.
Statement of Equivalence
The GRIPPER ® Micro 1.25 inch Needle is substantially equivalent to the currently marketed GRIPPER Micro Needles based on a comparison of the indications for use and the technological characteristics of the device.
Conclusion
The GRIPPER® Micro 1.25 inch Needle is substantially equivalent to the currently marketed GRIPPER Micro Needles based on the indications for use, technological characteristics, materials of construction and principles of operation of the device. Bench tests confirmed the suitability of the device for its intended use.
Traditional 510(k) - GRIPPER Micro 1.25 Smiths Medical ASD, Inc.
Confidential
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Image /page/4/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. There are also a series of dots on the left side of the seal.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Rachelle Parsons Senior Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
AUG 3 - 2010
Re: K101180
Trade/Device Name: GRIPPER® Micro Blunt Cannula Non- Coring Safety Needle Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 2, 2010 Received: July 6, 2010
Dear Ms. Parsons:
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. Parsons
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 (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.
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
Susan Munro
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
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K10/1180
SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification
GRIPPER® Micro Blunt Cannula Non-Coring Safety Needle Indications for Use
AUG 3 - 2010
510(k) Number: K101180
Device Name: GRIPPER® Micro Blunt Cannula Non-Coring Safety Needle
Indications for Use:
This product is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against accidental needlestick injuries.
Prescription Use X (Per 21 CFR 801 . 109)
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)
Ri C. C
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K1 01180
Traditional 510(k) - GRIPPER Micro 1.25 Smiths Medical ASD, Inc.
Confidential
§ 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.