(56 days)
The Confluent Surgical MicroMyst Applicator and Air Pump is indicated for use in the simultaneous delivery of two non- homogenous fluids or solutions onto a surgical site.
The MicroMyst Applicator and Air Pump will be configured using the following components:
Applicator with flexible tip
Air line with filter
Air Pump
The provided text is a 510(k) summary for the Confluent Surgical MicroMyst Applicator and Air Pump. This document focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against specific acceptance criteria for a novel AI/software medical device.
Therefore, many of the requested categories for AI/software medical device studies either do not apply or cannot be extracted from this document.
Here's an attempt to address the points based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not present specific, quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics in the way a study for an AI/software medical device would.
Instead, the "acceptance criteria" for this device's regulatory clearance is demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially that the device performs functionally similarly and safely to the predicates.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Safety: Device is safe for its intended use, comparable to predicates. | "Biocompatibility data and results of bench testing have been provided to support the safety and performance of the Confluent Surgical MicroMyst Applicator and Air Pump." |
| Performance: Device performs its intended function comparably to predicates. | "The data provided support that the MicroMyst Applicator and Air Pump is substantially equivalent to the currently marketed HemaMyst Surgical Applicator System (K994023) and the FibriJet® Aerosol Applicator (K012868)." |
| Similar Indications for Use: Indications are similar to predicates. | "Similarities in indication for use, operating principle, components and materials" noted. Indications are "simultaneous delivery of two non- homogenous fluids or solutions onto a surgical site," identical to or fully encompassed by predicates. |
| Similar Operating Principle: Operating principle is similar to predicates. | "Similarities in indication for use, operating principle, components and materials" noted. |
| Similar Components and Materials: Components and materials are similar or equivalent to predicates. | "Similarities in indication for use, operating principle, components and materials" noted. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/not specified. The document refers to "biocompatibility data and results of bench testing" but does not provide details on the sample size of these tests. This is not a study involving a "test set" of patient data for an algorithm.
- Data Provenance: Not applicable/not specified. Given it's bench testing and biocompatibility, concepts like "country of origin" or "retrospective/prospective" data sets for patient data do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical medical device, not an AI/software device requiring expert-established ground truth from images or other patient data. The "ground truth" here is the physical and biological properties of the device and its function as demonstrated through engineering tests and biocompatibility assessments.
4. Adjudication Method for the Test Set
Not applicable. There is no test set in the context of expert review and adjudication for an AI algorithm.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done. This type of study is relevant for evaluating human performance with and without an AI-assisted device, which is not the subject of this 510(k).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical applicator and air pump, not an algorithm.
7. The type of ground truth used
The "ground truth" used for this device's clearance would be based on:
- Engineering specifications and performance metrics during bench testing.
- Results from biocompatibility testing (e.g., cytotoxicity, sensitization, irritation studies).
- Chemical and material characterization.
- Comparison to the established safety and performance profiles of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/software device that requires a training set or ground truth for algorithmic training.
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JUN 1 5 2005
K050998
1 of 2
510(K) SUMMARY
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.
| Date Prepared: | April 15, 2005 |
|---|---|
| Sponsor | Confluent Surgical, Inc. |
| 101A First Avenue | |
| Waltham, MA 02451 | |
| Contact | Eric Ankerud |
| Phone: | (781) 693 2333 |
| Fax: | (781) 693 2363 |
| E-mail: | eankerud@confluentsurgical.com |
| Device Trade/Proprietary Name | Confluent Surgical MicroMyst Applicator and Air Pump |
| Classification Name | Piston Syringe (21 CFR 880.5860) |
| Class II | |
| Product Code: FMF | |
| Common Name | MicroMyst Applicator and Air Pump |
| Predicate Device(s) | HemaMyst Surgical Applicator SystemFibriJet Aerosol Applicator |
DEVICE DESCRIPTION
| Product Description | The MicroMyst Applicator and Air Pump will be configured using the following components: |
|---|---|
| Applicator with flexible tipAir line with filterAir Pump | |
| Indications for Use | The Confluent Surgical MicroMyst Applicator and Air Pump is indicated for use in the simultaneous delivery of two non- homogenous fluids or solutions onto a surgical site. |
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| Safety and Performance | Biocompatibility data and results of bench testing havebeen provided to support the safety and performance ofthe Confluent Surgical MicroMyst Applicator and AirPump.The data provided support that the MicroMyst Applicatorand Air Pump is substantially equivalent to the currentlymarketed HemaMyst Surgical Applicator System(K994023) and the FibriJet® Aerosol Applicator (K012868) |
|---|---|
| Conclusion | Based on 1) safety and performance data, and 2)similarities in indication for use, operating principle,components and materials the Confluent MicroMystApplicator and Air Pump has been shown to besubstantially equivalent to a predicate device under theFederal Food, Drug and Cosmetic Act. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2005
Mr. Eric P. Ankerud Vice President, Clinical, Regulatory & Quality Confluent Surgical, Incorporated 101A First Avenue Waltham, Massachusetts 02451
Re: K050998
Trade/Device Name: Confluent Surgical MicroMyst™ Applicator and Air Pump Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 15, 2005 Received: April 21, 2005
Dear Mr. Ankerud:
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. Ankerud
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" (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,
Senatie f. Michien Ond.
'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): ____________________________________________________________________________________________________________________________________________________
Confluent Surgical MicroMyst TM Applicator and Air Pump Device Name: The Confluent Surgical MicroMyst Applicator and Air Indications For Use: Pump is indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.
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)
Aaron Kagin For ADW
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Page 1 of
§ 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).