(191 days)
ICU Medical piston syringes are single use syringes that are intended for injecting fluids into or withdrawing fluids from the body.
The ICU Medical Single-use Syringes is a pre-sterilized, single-use disposable that is equivalent to the predicate device. It is made of a calibrated hollow barrel, a moveable piston or plunger. Only two of the components ever touch the fluids or blood: the barrel and piston tip. All components are made from existing biocompatible materials that are routinely used in the medical device industry. This device works with a small amount of lubricant for moving the piston shaft. The connection luer on the end is identical to the predicate device. Syringe sizes include: 1ml; 10ml; 20ml; and 30ml. The barrel is visually clear, and the plungers are available in multiple colors (for indication of contents per hospital protocol).
The provided text describes a 510(k) premarket notification for ICU Medical Syringes. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the way clinical studies for AI/software devices do.
Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth establishment, training set details) are not applicable to the information provided in this document as it's a submission for a physical medical device (syringes).
However, I can extract the relevant information from the document to answer the applicable sections.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (syringes), the "acceptance criteria" are typically conformity to recognized standards and demonstrating substantial equivalence in materials, performance, and operational features. The "performance" is implicitly deemed acceptable if these criteria are met.
| Acceptance Criteria / Standard | Reported Device Performance (ICU Medical Syringes) |
|---|---|
| Conformity to ISO 7886-1 (Sterile hypodermic syringes for single use) | "ICU Medical syringes will conform to the requirements of ISO 7886-1, an FDA recognized standard, prior to marketing the devices." |
| Sterility Assurance Level (SAL) | "ICU Medical's Sterility Assurance Level, (SAL) has an established history of meeting the 10⁻⁶ level." |
| Conformity to ISO 10993-1 (Biological evaluation of medical devices) for packaging and minimizing residual gases | "The single use syringes will be packaged in a way as to ensure conformity with ISO 10993-1, including minimizing residual gases." |
| Substantial Equivalence to Predicate Device (K024052 - Merit Medical Systems, Inc. syringe) | Materials (Polycarbonate barrel, Polyisoprene plunger tip), Calibrated Barrel Volume (YES), Sterilization method (EtO), Operational characteristics are identical. "The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent and are safe and effective for their intended use." |
| Biocompatibility | "All components are made from existing biocompatible materials that are routinely used in the medical device industry." |
| Latex-free | "Both the submitted device and the predicate are latex-free." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a physical device (syringes), not a clinical study involving a test set of data. The "testing" refers to meeting engineering and manufacturing standards.
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 as typically understood in AI/software device studies is not relevant here. Ground truth for the syringe device would be based on validated engineering specifications and performance benchmarks from recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 physical medical device, not an AI/software device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by conformance to recognized international standards (ISO 7886-1, ISO 10993-1), validated material specifications (biocompatibility), and demonstration of operational equivalence to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/software device that is "trained."
9. How the ground truth for the training set was established
Not applicable.
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OCT 5 2007
ICU MEDICAL INC.
4455 Atherton Drive Salt Lake City, Utah (801) 264 - 1332, Phone (801) 264 - 1755, Fax Tracy S. Best, Sr. Regulatory Affairs Specialist Preparation Date: March 23, 2007
510(K) Summary of Safety and Effectiveness for the:
| Trade Name: | ICU Medical Syringes, multiple sizes | |
|---|---|---|
| -- | ------------- | -------------------------------------- |
Common Name: Syringe, Hypodermic
Piston Syringe, 21 CFR 880.5860, Class II Device Classification Name:
Legally Marketed Predicate Devices for Substantial Equivalence:
*K024052 - Merit Medical Systems, Inc. (MMS)
Rationale for SE:
The MMS syringe is a Class II device pre-sterilized device that is intended for single use. Its components are: a calibrated hollow barrel and a moveable piston or plunger. At the end of the barrel, there is a tapered nozzle and a male luer hub. These are universal style connectors that are used for connecting a needle or connecting to other approved devices with a mating (female) luer connector. This predicate device, along with the submitted device operates similarly. The device works with a small amount of silicone oil that provides a lubricant for the moving piston shaft. The materials used in the submitted device and in the predicate devices are equivalent. The materials have previously been tested and accepted for biocompatibility and are widely accepted as medical industry grade material. Both the submitted device and the predicate are latex free.
Description of Submitted Device:
The ICU Medical Single-use Syringes is a pre-sterilized, single-use disposable that is equivalent to the predicate device. It is made of a calibrated hollow barrel, a moveable piston or plunger. Only two of the components ever touch the fluids or blood: the barrel and piston tip. All components are made from existing biocompatible materials that are routinely used in the medical device industry. This device works with a small amount of lubricant for moving the piston shaft. The connection luer on the end is identical to the predicate device. Syringe sizes include: 1ml; 10ml; 20ml; and 30ml. The barrel is visually clear, and the plungers are available in multiple colors (for indication of contents per hospital protocol).
Intended Uses of the ICU Medical Syringe:
ICU Medical piston syringes are single use syringes that are intended for injecting fluids into or withdrawing fluids from the body.
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Technological Characteristics and Substantial Equivalence Table:
| Component: | ICU Medical, Inc. | Merit Medical, Inc. |
|---|---|---|
| Syringe Barrel: | Polycarbonate | Polycarbonate |
| Plunger Tip: | Polyisoprene | Polyisoprene |
| Calibrated Barrel Volume: | YES | YES |
| Sterilization method: | EtO | EtO |
| 510(k) Approval | This submission | K024052 |
The operational characteristics are identical in that by manually advancing or withdrawing the plunger in the barrel to express or withdraw fluids. Operation is the same for all piston syringes, including the predicate device.
Safety and Performance:
ICU Medical syringes will conform to the requirements of ISO 7886-1, an FDA recognized standard, prior to marketing the devices. Additionally, ICU Medical's Sterility Assurance Level, (SAL) has an established history of meeting the 10° level. The single use syringes will be packaged in a way as to ensure conformity with ISO 10993-1, including minimizing residual gases.
Conclusion:
The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent and are safe and effective for their intended use.
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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 human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tracy S. Best Senior Regulatory Affairs Specialist ICU Medical, Incorporated 4455 South Atherton Drive Salt Lake City, Utah 84123
OCT 5 ° 2007
Re: K070856
Trade/Device Name: ICU Medical Sterile Disposable Piston Syringes, Sizes: Iml; 3ml; 6ml; 10ml; 20ml; & 30ml Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 24, 2007 Received: September 25, 2007
Dear Mr. Best:
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.
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Page 2 - Mr. Best
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 (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), please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
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
510(k) Number (if known):
Device Name:
ICU Medical sterile disposable piston syringes, Sizes: 1ml; 3ml; 10ml; 20ml; & 30ml
Indications for Use:
ICU Medical piston syringes are single use syringes that are intended for injecting fluids into or withdrawing fluids from the body.
Prescription Use _ XX (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)
Cinta Lanto
(Tision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).