(65 days)
The Confluent Surgical MicroMyst Applicator and Air Pump are indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.
The Confluent Surgical MicroMyst Applicator will be configured using the following components: Applicator Air line with Filter Air Source
The provided text describes a 510(k) summary for the Confluent Surgical MicroMyst Applicator and Air Pump and its clearance by the FDA. However, it does not contain any information regarding acceptance criteria, device performance metrics, or details of a study that would prove the device meets specific acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Confluent Surgical MicroMyst Applicator and Air Pump K050998) based on similar technological characteristics, indications for use, operating principle, design, materials, and manufacturing processes. It states that "Testing conducted to characterize performance of the proposed device incorporating the modification discussed in this submission has demonstrated that it is substantially equivalent to the predicate device and that it is suitable for the intended use specified." but provides no details about this testing.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number and qualifications of experts for ground truth establishment
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document is a regulatory submission for device clearance based on substantial equivalence, not a detailed study report with performance metrics against pre-defined acceptance criteria.
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CONFIDENTIAL
MAY 3 0 2007
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.
| Sponsor: | Confluent Surgical, Inc.101A First AvenueWaltham, MA 02451 | |
|---|---|---|
| Contact: | Kristine Burke | |
| Phone: | (781) 839-1738 | |
| Fax: | (781) 839-1763 | |
| E-mail: | Kristine.Burke@tycohealthcare.com | |
| Device Trade/Proprietary Name(s) | Confluent Surgical MicroMyst ApplicatorConfluent Surgical Air Pump | |
| Classification Name: | Piston Syringe (21 CFR 880.5860)Class IIProduct Code: FMF | |
| Common Name: | Confluent Surgical MicroMyst Applicator and ConfluentSurgical Air Pump | |
| Predicate Device(s): | Confluent Surgical MicroMyst Applicator and Air Pump(K050998) | |
| DEVICE DESCRIPTION | ||
| Product Description: | The Confluent Surgical MicroMyst Applicator will beconfigured using the following components:ApplicatorAir line with FilterAir Source | |
| Indications for Use: | The Confluent Surgical MicroMyst Applicator and AirPump are indicated for use in the simultaneous delivery oftwo non-homogenous fluids or solutions onto a surgicalsite. | |
| Technological Characteristics: | The proposed device incorporating the modificationdiscussed in this submission has similar technologicalcharacteristics compared to the predicate device | |
| Safety and Performance: | Testing conducted to characterize performance of theproposed device incorporating the modification discussedin this submission has demonstrated that it is substantiallyequivalent to the predicate device and that it is suitable forthe intended use specified. | |
| Conclusion: | Based on (1) safety and performance data, and (2)similarities in indication for use, operating principle,design, materials, and manufacturing processes, theConfluent Surgical MicroMyst Applicator has been shownto be substantially equivalent to a predicate device underthe Federal Food, Drug and Cosmetic Act. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare. The caduceus consists of a staff with two snakes coiled around it, topped with a pair of wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2007
Ms. Kristine Burke Regulatory Affairs Manager Confluent Surgical, Incorporated 101A First Avenue Waltham, Massachusetts 02451
Re: K070814
Trade/Device Name: Confluent Surgical MicroMyst™ Applicator and Air Pump Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 09, 2007 Received: May 10, 2007
Dear Ms. Burke:
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. Burke
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Chiu Lin, Ph.D.
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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CONFIDENTIAL
Page 1_of 1
Indications for Use Statement
| 510(k) Number (if known): | |
|---|---|
| Device Name: | Confluent Surgical MicroMyst™ Applicator and Air Pump |
| Indications for Use: | The Confluent Surgical MicroMyst Applicator and Air Pump are indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site. |
Prescription Use
(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)
Arun
ா Sign-Off) Cosion of Anesthesiology, General Hospital, imection Control, Dental Devices
2(k) Number: K479814
Confluent Surgical, Inc. MicroMyst Applicator
Special Premarket Notification [510(k)]: Device Modification March 23, 2007
هاندهایت - رادیکیت
§ 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).