(82 days)
The NOW Huber Clear™ Safety Infusion Set is a safety IV administration set with a non-coring, ninety-degree, right-angle Huber needle, used to access surgically implanted vascular ports. The Huber needle is used to administer fluids or to withdraw blood. The Huber Clear™ system facilitates safe removal of the needle by encapsulating the needle within the attachment wings to help prevent needlestick injuries when using the device for vascular port access.
The NOW Huber Clear™ Safety Infusion Set is a standard non-coring right angle Huber needle and administration set with a needlestick prevention feature. The Huber Clear™ Safety Infusion Set is designed for use with a vascular access infusion system. The NOW Huber Clear™ Safety Infusion Set is fabricated from biocompatible, medical grade materials. The needle is inserted into the vascular access port in a standard manner for fluid infusion or for blood sampling. Removal of the needle is done as with any standard Huber needle, using a one-handed (dominant hand) technique to pull out the needle, and stabilizing the port with the nondominant hand. As the needle is removed, the passive needlestick prevention feature actuates automatically when the users hands are positioned correctly and can be easily seen, felt, and heard by the user to ensure that the needle cover is secure. The NOW Huber Clear™ Safety Infusion Set is supplied sterile and nonpyrogenic, for single use only.
The provided document describes a medical device, the "NOW Huber Clear™ Safety Infusion Set," but it does not contain the specific information required to complete the detailed table about acceptance criteria and a study proving those criteria were met. The document states that "Equivalency performance testing has been performed on the Now Huber Clear™ Safety Infusion Set components that have been modified from the predicate Huber Plus. In addition, a Simulated Use Study was performed showing that there were no incidences of sharps injuries or incidences where the safety feature failed to be activated during the course of the study." However, it does not provide quantitative acceptance criteria, detailed performance metrics, sample sizes for the simulated use study, ground truth details, or information about expert involvement.
Therefore, much of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| Qualitative: No incidences of sharps injuries | No incidences of sharps injuries were reported during the Simulated Use Study. |
| Qualitative: No incidences where the safety feature failed to be activated | No incidences where the safety feature failed to be activated were reported during the Simulated Use Study. |
Note: The document only provides qualitative outcomes from a "Simulated Use Study" without specific, measurable acceptance criteria or detailed numerical performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The document only mentions a "Simulated Use Study."
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document does not mention the involvement of experts in establishing ground truth for the "Simulated Use Study."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. There is no information regarding an adjudication method for the "Simulated Use Study."
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. This device is a physical safety infusion set, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI-related metrics are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical medical device. The "Simulated Use Study" would have involved human users interacting with the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the "Simulated Use Study" appears to be direct observation of the absence of sharps injuries and successful activation of the safety feature during simulated use by actual users (though the number or type of users is not specified). This aligns most closely with performance observed during the study rather than an external, pre-established ground truth like pathology or expert consensus.
8. The sample size for the training set
- Not applicable/not specified. The device is a physical product, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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JUL 12 2005
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NOW MEDICAL DISTRIBUTION HUBER CLEAR™ SAFETY INFUSION SET 510(k) PREMARKET NOTIFICATION
510(k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SODA and 21CFR § 807.92
| Submitted by: | NOW Medical Distribution, Inc.PO Box 936Chadds Ford, PA 19317 |
|---|---|
| Contact Person: | Christine EmanuelRegulatory Consultant(805) 963-4312 (tel)(805) 564-8642 (fax) |
| Date Prepared: | April 15, 2005 |
| Device Name: | |
| Proprietary Name: | NOW Huber Clear™ Safety Infusion Set |
| Common Name: | Huber Needle and Administration Set |
|---|---|
| Classification: | Class II: Product Code FPARegulation Number 21 CFR 880.5440 |
Identification of Predicate Devices
- NOW Huber Plus Safety Infusion Set, NOW Medical Distribution, Chadds Ford, PA ● K993848
Device Description:
The NOW Huber Clear™ Safety Infusion Set is a standard non-coring right angle Huber needle and administration set with a needlestick prevention feature. The Huber Cleartist Safety Infusion Set is designed for use with a vascular access infusion system.
The NOW Huber Clear™ Safety Infusion Set is fabricated from biocompatible, medical grade materials. The needle is inserted into the vascular access port in a standard manner for fluid infusion or for blood sampling. Removal of the needle is done as with any standard Huber needle, using a one-handed (dominant hand) technique to pull out the needle, and stabilizing the port with the nondominant hand. As the needle is removed, the passive needlestick
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NOW MEDICAL DISTRIBUTION HUBER CLEAR™ SAFETY INFUSION SET 510(k) PREMARKET NOTIFICATION
prevention feature actuates automatically when the users hands are positioned correctly and can be easily seen, felt, and heard by the user to ensure that the needle cover is secure.
The NOW Huber Clear™ Safety Infusion Set is supplied sterile and nonpyrogenic, for single use only.
Indication for Use:
The NOW Huber Clear™ Safety Infusion Set is a safety IV administration set with a noncoring, ninety-degree, right-angle Huber needle, used to access surgically implanted vascular ports. The Huber needle is used to administer fluids or to withdraw blood. The Huber Clear™ system facilitates safe removal of the needle by encapsulating the needle within the attachment wings to help prevent needlestick injuries when using the device for vascular port access.
Technological Characteristics
The Now Huber Clear™ Safety Infusion Set is a modification of the Huber Plus Safety Infusion Set, and encompasses no new technology.
Performance Data
Equivalency performance testing has been performed on the Now Huber Clear™ Safety Infusion Set components that have been modified from the predicate Huber Plus. In addition, a Simulated Use Study was performed showing that there were no incidences of sharps injuries or incidences where the safety feature failed to be activated during the course of the study.
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Image /page/2/Picture/2 description: The image shows a circular logo. The logo features a stylized depiction of an eagle or bird in flight, with three curved lines representing its wings and body. The bird is facing to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
JUL I 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Now Medical Distribution, Incorporated C/O Ms. Christine Emanuel Tecsa Technical Services 1205 De La Vina Street Santa Barbara, California 93101
Re: K051009
Trade/Device Name: NOW Huber Clear™ Safety Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 20, 2005 Received: April 26, 2005
Dear Ms. Emanuel:
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 Eederal Register.
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Page 2 - Ms. Emanuel
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) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CT R 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,
Qum Syllom be
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
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KD51009
Indications For Use
510(k) Number (if known): ____K051009
Device Name:_NOW Huber Clear™ Safety Infusion Set
Indications For Use:
Indications For Use.
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Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number .
Page 1 of 1
§ 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.