(328 days)
The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
The 0.9% Sodium Chloride Flush Syringe is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for use in flushing compatible intravenous administration sets and industrials and individually
The proposed device is a sterile, single use, standard piston syringe of various sizes and fill volumes containing either 10 or 100 USP Heparin units/ml, or, 0.9% Sodium Chloride USP.
This document describes the Kendall Monoject® Prefill Flush Syringes, which contain either heparin or 0.9% sodium chloride, and are intended for flushing intravenous tubing and access devices. The submission focuses on substantial equivalence to predicate devices, particularly regarding a change in the manufacturing process rather than an AI/ML device. Therefore, many of the requested criteria for AI/ML devices, such as those related to AI-specific performance metrics, reader studies, and ground truth establishment, are not applicable or not provided in this regulatory document.
Here's the information that can be extracted or inferred from the provided text, primarily focusing on the non-AI aspects of the device and its testing:
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) summary for a medical device (pre-filled syringes) and not an AI/ML device, the "acceptance criteria" and "reported device performance" are based on traditional non-clinical testing for safety, function, and stability, rather than diagnostic accuracy metrics. The document states:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Microbiological Testing | Verification testing was performed. |
| Physical Testing | Verification testing was performed. |
| Functional Testing | Verification testing was performed. |
| Product Stability Testing | Verification testing was performed. |
Note: The document only states that "Verification testing for the proposed change involved microbiological, physical, functional and product stability testing." It does not provide specific acceptance thresholds or detailed numerical results for these tests. The outcome of these tests was a determination of substantial equivalence (K032438).
Study Details
- 1. Sample sized used for the test set and the data provenance: Not applicable or not specified for an AI/ML device context. The verification testing mentioned (microbiological, physical, functional, product stability) would have involved sample sizes appropriate for those specific types of engineering tests. No details on these sample sizes are provided.
- 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device requiring expert ground truth for classification or diagnosis.
- 3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not an AI/ML diagnostic or classification device.
- 4. 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: Not applicable. This is not an AI/ML device and no MRMC study was conducted or is relevant.
- 5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- 6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. For the non-clinical testing, the "ground truth" would be established by validated test methods and specifications for sterility, physical properties (e.g., flow rate, burst strength), functional performance (e.g., proper flush), and stability (e.g., shelf-life studies).
- 7. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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JUN 3 0 2004
EXHIBIT # 7
Page 1 of 2
510(k) Summarv
In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
The Kendall Company 15 Hampshire Street Mansfield, MA 02048 Date Prepared: August 4, 2003
- Contact Person
David A. Olson Vice President, Regulatory Affairs (508) 261-8530
-
- Name of Medical Device
Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Common or Usual Name: Monoject® Prefill Flush Syringes
- Name of Medical Device
3. Identification of Legally Marketed Device
The proposed Kendall Monoject® Prefill Flush Syringes are substantially equivalent in intended use, function and composition to the currently marketed Monoject ParFill Sodium Chloride and Heparin Lock Flush Syringes, 510(k) numbers K011283 and K013556.
4. Device Description
The proposed device is a sterile, single use, standard piston syringe of various sizes and fill volumes containing either 10 or 100 USP Heparin units/ml, or, 0.9% Sodium Chloride USP.
-
- Device Intended Use
The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
- Device Intended Use
-
- Product Comparison
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The proposed device has the same technological characteristics and indical use as the predicate devices. The proposed modification involves a change in the manufacturing process.
7. Nonclinical Testing
Verification testing for the proposed change involved microbiological, physical, functional and product stability testing.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2004
Tyco Healthcare Mr. David A. Olson Vice President, Regulatory Affairs Kendall 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K032438
Trade/Device Name: Monoject 0.9% Sodium Chloride and Heparin Lock Flush Syringe Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: April 29, 2004 Received: May 3, 2004
Dear Mr. Olson:
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 - Mr. Olson
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely vours.
Clive
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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Indications for Use Statement
510(k) Number (if known):
Device Name: Monoject 0.9% Sodium Chloride and Heparin Lock Flush Syringe
Indications for Use: The 0.9% Sodium Chloride Flush Syringe is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for use in flushing compatible intravenous administration sets and industrials and individually
Please Do Not Write Below This Line – Continue On Another Page If Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental
510(k) Number: K032438
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).