(56 days)
K994023, K 012868
K994023, K 012868
No
The description focuses on the mechanical delivery of fluids and does not mention any AI/ML components or functions.
Yes
The device is used for the simultaneous delivery of fluids or solutions onto a surgical site to aid in a medical procedure, which is a therapeutic application.
No
The device is used for the simultaneous delivery of two fluids or solutions onto a surgical site, with no indication of diagnosing any condition. Its intended use is therapeutic/surgical application, not diagnostic.
No
The device description explicitly lists physical components: Applicator with flexible tip, Air line with filter, and Air Pump. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver fluids onto a surgical site. This is a direct application to the body during a surgical procedure, not for testing samples in vitro (outside the body).
- Device Description: The components (applicator, air line, air pump) are designed for delivering substances, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely for delivering substances during surgery.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The MicroMyst Applicator and Air Pump will be configured using the following components: Applicator with flexible tip, Air line with filter, Air Pump
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
onto a surgical site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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 (K 012868)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HemaMyst Surgical Applicator System, FibriJet® Aerosol Applicator
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K994023, K 012868
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 System |
| FibriJet 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. |
1
| Safety and Performance | 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.
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 (K
012868) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based on 1) safety and performance data, and 2)
similarities in indication for use, operating principle,
components and materials the Confluent MicroMyst
Applicator and Air Pump has been shown to be
substantially equivalent to a predicate device under the
Federal Food, Drug and Cosmetic Act. |
2
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.
3
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
4
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