(73 days)
The MicroMyst Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.
The MicroMyst Applicator will be configured using the following components: Applicator (14cm long, multi-lumen shaft that provides separate channels for the flow of two fluids and filtered air) Air line with filter (a poly (vinyl chloride) tubing with an integral 0.2 µL filter; the free end of this tubing connects to a flow source or flow-regulator)
The provided text is related to a 510(k) submission for a medical device called the "MicroMyst Applicator." However, it focuses primarily on regulatory approval and equivalence to a predicate device, and does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving device performance as outlined in your prompt.
The document highlights:
- Device: MicroMyst Applicator
- Indication for Use: Simultaneous delivery of two non-homogenous solutions onto a surgical site.
- Safety and Effectiveness: Stated to be demonstrated through biocompatibility and in vitro bench testing, supporting substantial equivalence to a predicate device.
- Conclusion: The device is substantially equivalent to a predicate device based on safety and effectiveness data, same indications for use, and same operating principle.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study that proves the device meets specific performance criteria from the provided text. The document describes a regulatory submission for a device, not a performance study with detailed methodology, results, or ground truth establishment.
To answer your questions accurately, I would need a document that describes:
- Specific performance metrics for the device (e.g., flow rate accuracy, mist uniformity, delivery precision).
- Quantifiable acceptance criteria for those metrics.
- Details of a study (e.g., bench testing, clinical trial) that measured these metrics.
- The results of that study compared to the acceptance criteria.
- Information on sample sizes, ground truth establishment, expert involvement, and statistical methods.
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SECTION 5: 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 §807.92.
| 510(k) Summary | |
|---|---|
| Date Prepared: | August 25, 2008 |
| Sponsor | Confluent Surgical, Inc. (Covidien)101A First AvenueWaltham, MA 02451 |
| Contact | Virginia VetterPhone: (781) 839 1755Fax: (781) 839 1763E-mail: Virginia.Vetter@covidien.com |
| Device Trade/Proprietary Name | MicroMyst Applicator |
| Classification Name | Piston Syringe (21 CFR 880.5860)Class IIProduct Code: FMF |
| Common Name | MicroMyst Applicator |
| Predicate Device(s) | Confluent Surgical MicroMyst Applicator and Air Pump |
| DEVICE DESCRIPTION | |
| Product Description | The MicroMyst Applicator will be configured using thefollowing components:Applicator (14cm long, multi-lumen shaft thatprovides separate channels for the flow of twofluids and filtered air) Air line with filter (a poly (vinyl chloride)tubing with an integral 0.2 µL filter; the free endof this tubing connects to a flow source or flow-regulator) |
| Indications for Use | The MicroMyst Applicator is indicated for use in thesimultaneous delivery of two non-homogenous solutionsonto a surgical site. |
| Safety and Effectiveness | Safety and effectiveness of the MicroMyst Applicatorhave been demonstrated in this submission. Thebiocompatibility and in vitro bench testing data providedsupports Confluent Surgical's (Covidien's) belief that theMicroMyst Applicator is substantially equivalent to thecurrently 510(k)-cleared Confluent Surgical MicroMystApplicator and Air Pump. |
| Conclusion | Safety and effectiveness data, same indications for useand same operating principle show the MicroMystApplicator to be substantially equivalent to a predicatedevice under the Federal Food, Drug and Cosmetic Act. |
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Image /page/1/Picture/2 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN..." on the left side and "USA" on the right side. The central symbol consists of three stylized, overlapping shapes that resemble a bird or abstract human figure.
NOV ~ 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Virginia Vetter Regulatory Affairs Specialist Covidien Confluent Surgical, Incorporated 101A First Avenue Waltham, Massachusetts 02451
Re: K082454
Trade/Device Name: MicroMyst Applicator™ Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 15, 2008 Received: October 15, 2008
Dear Ms. Vetter:
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 -- Ms. Vetter
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Suite Y. Michie Omd.
Chiu S. Lin, Ph. D Division 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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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Unknown
Device Name: MicroMyst Applicator™
Indications for Use:
The MicroMyst Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.
Prescription Use _ X (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)
Anthony D. Wahl
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082454
CONFIDENTIAL
Confluent Surgical, Inc. (Covidien)
Page 10 of 32
§ 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).