(92 days)
0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device.
The Predicate Device, 510(k) Number: K984590 (Baxter Healthcare), consists of a sterile plastic syringe aseptically filled with 0.9% Sodium Chloride Flush Solution. The predicate device is fluid path sterile with a Sterility Assurance Level (SAL) of 10 . This is a single use device. AMUSA is the legal owner of the Baxter 510(k) K984590.
The Modified Device, the subject of this 510 (k), consists of a non-sterile plastic syringe filled with 0.9% Sodium Chloride Flush Solution that is sterilized by the addition of terminal sterilization (Radiation). The modified device is fluid path sterility Assurance Level (SAL) of 10 This is a single use device.
The provided text describes a 510(k) summary for a medical device called "0.9% Sodium Chloride Flush Syringe". This document is a premarket notification to the FDA to demonstrate that the modified device is substantially equivalent to a legally marketed predicate device.
Crucially, this document is for a medical device (syringe) and not an AI/ML software device. Therefore, the concepts of "acceptance criteria for an AI device", "study that proves the device meets the acceptance criteria", "sample size for test set", "ground truth", "number of experts", "adjudication method", "MRMC study", "standalone performance", and "training set" are not applicable in the context of this 510(k) submission.
The document focuses on demonstrating substantial equivalence through non-clinical verification testing due to a change in the sterilization process, not on the performance of a diagnostic or predictive algorithm.
However, based on the provided text, I can extract information related to the device and its assessment:
1. A table of acceptance criteria and the reported device performance
Since this is a non-AI/ML device, the concept of "acceptance criteria" is related to its physical, chemical, and functional properties, as well as its sterility and stability, rather than diagnostic performance metrics.
| Acceptance Criterion Type | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) | 10⁻⁶ |
| Intended Use Equivalence | "The modified terminally sterilized syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended." |
| Design Equivalence | "The technical characteristics for the modified device do not differ from those of the currently marketed device. These devices have the same design, the same fundamental scientific characteristics, the same labeling, and have the same intended use." |
| Process Change Justification | Change from aseptically filled (predicate) to terminally sterilized (radiation) (modified device) |
| Non-clinical Verification Testing | Passed chemical-physical, functional, and product stability testing. |
2. Sample sized 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 explicitly stated. The document refers to "non-clinical verification testing" which would involve a set of syringes, but the specific number tested is not provided in this summary.
- Data Provenance: Not applicable in the context of data for an AI/ML model. The testing was performed on the modified syringe product itself. Location of testing and specific methodology are not detailed in this summary.
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 applicable. "Ground truth" in the AI/ML sense is not relevant here. The assessment is based on physical, chemical, and biological testing, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring expert adjudication of outputs.
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
Not applicable. This is a medical device (syringe), not an AI/ML diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" for this device relates to meeting established engineering and sterility standards through laboratory testing (e.g., measuring chemical composition, mechanical strength, sterility testing results, stability over time).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable.
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111034
JUL 1 4 2011
5.122
510(k) Summary
-- 510(k) Summary of Safety and Effectiveness
As required by 809,92(a)(2).
SPECIAL 510 (k) PREMARKET NOTIFICATION NUMBER: _
Submitter and Owner of the 510(k)
AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: 615-833-2699 Fax: 615-332-9945
Official Correspondent
Karen Thomison Director of Quality Assurance AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: 615-833-2699 Fax: 615-332-9945
Date of Preparation
April 4, 2011
510(k) Application Number
Trade/Proprietary Name
0.9% Sodium Chloride Flush Syringe
Common Name/Usual Name Saline Flush Syringe
Device Classification Name Device, Flush, Vascular Access
Regulation Number 880.5200
Device Class Class II Device
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2111034
p.2 of 2
7
510(k) Summary
-Classification Panel --
General Hospital
Classification Product Code
NGT
INDICATIONS FOR USE
Intended use: 0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device.
DEVICE DESCRIPTION:
The Predicate Device, 510(k) Number: K984590 (Baxter Healthcare), consists of a sterile plastic syringe aseptically filled with 0.9% Sodium Chloride Flush Solution. The predicate device is fluid path sterile with a Sterility Assurance Level (SAL) of 10 . This is a single use device. AMUSA is the legal owner of the Baxter 510(k) K984590.
The Modified Device, the subject of this 510 (k), consists of a non-sterile plastic syringe filled with 0.9% Sodium Chloride Flush Solution that is sterilized by the addition of terminal sterilization (Radiation). The modified device is fluid path sterility Assurance Level (SAL) of 10 This is a single use device.
TECHNICAL DATA: The technical characteristics for the modified device do not differ from those of the currently marketed device. These devices have the same design, the same fundamental scientific characteristics, the same labeling, and have the same intended use. The proposed modification involves a change in the process. All other aspects of the product design remain the same.
Substantial Equivalence: Non-clinical verification testing for the proposed change involved chemical-physical, functional, and product stability testing. The results of testing conducted verifies the modified terminally sterilized syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended. Other companies have FDA clearance for special 510(k) s submitted with similar changes.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of one.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Karen Thomison Director of Quality Assurance AM USA 5209 Lindbar Drive, Suite 640 Nashville, Tennessee 37217
JUL 1 4 2011
Re: K111034
Trade/Device Name: 0.9% Sodium Chloride Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: June 20, 2011 Received: June 24, 2011
Dear Ms. Thomison:
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. Thomison
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFD A/CentersOffices/CDRH/CDR HOffices/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/Report aProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony V. Mutoon
Cinthism U. on ataen
Anthony D. Watson, B.S., M.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
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Indications for Use
Attachment 1
Indications for Use Statement
510(k) Number (if known): __
Device Name: 0.9% Sodium Chloride Flush Syringe
Indications for Use:
"0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device".
· Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elaine S. Marshall
Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K111034
§ 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).