(189 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI or ML.
No
The device is described as an applicator for irrigating or instilling fluids, which is a delivery mechanism, not a treatment in itself. Its purpose is to deliver fluids to a treatment site, rather than providing therapy directly.
No
The device is described as being for "irrigat[ing] or instill[ing] fluids to a wound or body cavity," which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (applicator instrument, replaceable spray tip, stainless steel hypodermic tube, molded polymer luer lock connector, stainless steel sheath) and physical testing (leak test, flow test, pull test, fit and sealing). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "irrigate or instill fluids to a wound or body cavity." This describes a therapeutic or procedural use, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a mechanical device for delivering fluids. It does not mention any components or processes related to analyzing biological samples.
- Lack of Diagnostic Information: There is no mention of the device being used to obtain information about a patient's health status through the analysis of biological samples.
The device is a tool for delivering fluids during medical procedures, not for performing diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
The Single Cannula Extended Applicator is intended for medical purposes to irrigate or instill fluid to a wound or body cavity.
Product codes
KYZ
Device Description
The Single Cannula Extended Applicator has two components: an applicator instrument and a replaceable spray tip. The spray tip is assembled to the instrument by the user. The assembled applicator product is installed on a standard medical syringe, and allows fluids to be applied from the syringe to a treatment site that is otherwise difficult to access. The entire device is packaged sterile and labeled for single-use.
The applicator instrument contains a stainless steel hypodermic tube with a molded polymer luer lock connector on the input (proximal) end. It is enclosed in a stainless steel sheath that provides rigidity and allows the device to effectively seal off in a 5mm endoscopic cannula. A replaceable molded polymer spray tip is attached to the output (distal) end of the sleeve by the user. A replacement tip is included in the package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound or body cavity
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
No clinical tests have been performed on the Single Cannula Extended Applicator or the predicate. Twenty years of marketing the predicate has shown the product to be safe & effective. Nearly 23000 predicate devices have been sold in the past 3 years.
Nonclinical tests: Leak test, Flow test, Pull test, Fit and sealing in 5mm endoscopic cannula, ISO-594-1 Conical fittings with 6% (Luer) taper. All test results meet the acceptance criteria and demonstrate that the device is appropriately designed for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6960 Irrigating syringe.
(a)
Identification. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
K102563
510(k) SUMMARY
| DATE OF SUMMARY: | October 28, 2010 |
|---|---|
| MAR 15 2011 | |
| OWNER: | Micromedics, Inc. |
| 1270 Eagan Industrial Road, Ste. 120 | |
| ST. Paul, MN 55121 | |
| CONTACT PERSON: | Tom Lopac |
| Manager, Quality Assurance and Regulatory Affairs | |
| Telephone: 651-452-1977 | |
| Fax: 651-452-1787 | |
| DEVICE TRADE NAME: | Single Cannula Extended Applicator |
| COMMON NAME: | Biomaterial Applicator |
| CLASSIFICATION NAME: | Irrigating Syringe |
PREDICATE DEVICE(S):
1 - 1
| Device | Company | Previous
510(k) | Clearance
Date |
|---------------------------|-------------------|--------------------|-------------------|
| Biomaterial Spray Syringe | Micromedics, Inc. | K982372 | 7-22-1998 |
DESCRIPTION OF THE DEVICE:
The Single Cannula Extended Applicator has two components: an applicator instrument and a replaceable spray tip. The spray tip is assembled to the instrument by the user. The assembled applicator product is installed on a standard medical syringe, and allows fluids to be applied from the syringe to a treatment site that is otherwise difficult to access. The entire device is packaged sterile and labeled for single-use.
The applicator instrument contains a stainless steel hypodermic tube with a molded polymer luer lock connector on the input (proximal) end. It is enclosed in a stainless steel sheath that provides rigidity and allows the device to effectively seal off in a 5mm endoscopic cannula. A replaceable molded polymer spray tip is attached to the output (distal) end of the sleeve by the user. A replacement tip is included in the package.
STATEMENT OF INTENDED USE:
The Single Cannula Extended Applicator is intended for medical purposes to irrigate or instill fluid to a wound or body cavity.
1
510(k) SUMMARY (CONTINUED)
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The Single Cannula Extended Applicator is identical to the predicate devices in intended use, function, method of operating and performance.
| Characteristic | Current Application:
Single Cannula Extended Applicator | Predicate Device:
Biomaterial Spray Syringe
510(k) K982372 (exempt) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The single Cannula Extended
Applicator is intended for medical
purposes to irrigate or instill fluids to a
wound or body cavity. | The Biomaterial Spray Syringe is
intended for medical purposes to irrigate
or instill fluids to a wound or body
cavity. |
| System
Components | 1) Applicator instrument
2) Spray tip | 1) Spray tip |
| Input | Standard medical syringe | Single standard medical syringe |
| Output | Single spray | Single spray |
| Power source | None - syringe is manually activated | None - syringe is manually activated |
| Compatibility
with other
devices | 1) Used with single standard medical
syringe
2) Fits into 5 mm endoscopic cannula | 1) Used with single standard medical
syringe |
| Materials | Stainless steel
ABS polymer | ABS polymer |
| Sterility | Sterilized to 10-6 SAL by EO gas,
single-use | Sterilized to 10-6 SAL by EO gas,
single-use |
| Biocompatibility | Tested in accordance with ISO 10993 | Tested in accordance with ISO 10993 |
Device Comparison Table
DISCUSSION OF NONCLINICAL TESTS:
Micromedics, Inc. conducts risk analysis and design verification tests are based on the result of these analyses. The tests performed are listed below. All test results meet the acceptance criteria and demonstrate that the device is appropriately designed for the intended use. Testing included:
- . Leak test
- Flow test .
- Pull test ●
- Fit and sealing in 5mm endoscopic cannula .
- . ISO-594-1 Conical fittings with 6% (Luer) taper
DISCUSSION OF CLINICAL TESTS:
No clinical tests have been performed on the Single Cannula Extended Applicator or the predicate. Twenty years of marketing the predicate has shown the product to be safe & effective. Nearly 23000 predicate devices have been sold in the past 3 years.
CONCLUSION:
The Single Cannula Extended Applicator is substantially equivalent to the predicate device(s) and does not introduce any new risks.
Page 5-2
2
510(k) SUMMARY (CONTINUED)
510(k) STATEMENT (As Required by 807.93)
I certify that, in my capacity as the Quality Manager for Micromedics, Inc., I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
Signed:
Tom Loper, Quality Manager
Tom Lopac, Quality Manager
Date: 11-16-68
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Tom Lopac Manager of Quality Assurance & Regulatory Affairs Micromedics, Incorporated 1270 Eagan Industrial Road, Suite 120 Saint Paul, Minnesota 55121-1385
MAR 1 5 2011
Re: K102563
Trade/Device Name: Single Cannula Extended Applicator Regulation Number: 21 CFR 880.6960 Regulation Name: Irrigating Syringe Regulatory Class: I Product Code: KYZ Dated: February 15, 2011 Received: February 16, 2011
Dear Mr. Lopac:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2- Mr. Lopac
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Single Cannula Extended Applicator
Indications for Use:
The Single Cannula Extended Applicator is intended for medical purposes to irrigate or instill fluids to a wound or body cavity.
.
Prescription Use: X (Per 21 CFT 801.109)
OR
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | 3/14/11 |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K102563 |
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