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.

AI/ML Overview

The provided document describes a 510(k) submission for a medical device called the "Single Cannula Extended Applicator." This device is intended for medical purposes to irrigate or instill fluid to a wound or body cavity. The submission aims to demonstrate substantial equivalence to a predicate device, the "Biomaterial Spray Syringe" (K982372).

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission details nonclinical tests performed to demonstrate the device's design suitability for its intended use. The document states, "All test results meet the acceptance criteria and demonstrate that the device is appropriately designed for the intended use." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the types of tests performed.

Test Type	Acceptance Criteria (Not Explicitly Stated Quantitatively)	Reported Device Performance
Leak test	(Implied: No leaks to be observed)	Met acceptance criteria
Flow test	(Implied: Adequate fluid flow)	Met acceptance criteria
Pull test	(Implied: Sufficient strength/retention)	Met acceptance criteria
Fit and sealing in 5mm endoscopic cannula	(Implied: Proper fit and seal)	Met acceptance criteria
ISO-594-1 Conical fittings with 6% (Luer) taper	(Implied: Conformance to ISO standard)	Met acceptance criteria

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes for the nonclinical tests (Leak test, Flow test, Pull test, Fit and sealing, ISO-594-1). It only states that "Micromedics, Inc. conducts risk analysis and design verification tests are based on the result of these analyses."

Regarding data provenance, all listed tests are nonclinical, performed by the manufacturer, Micromedics, Inc. Therefore, the data provenance is internal to the manufacturer, within the United States (where Micromedics, Inc. is located). The testing is prospective for the current device and retrospective in terms of experience with the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the document describes nonclinical tests, not a study involving expert-established ground truth for medical imaging or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The submission explicitly states: "No clinical tests have been performed on the Single Cannula Extended Applicator or the predicate."

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not conducted. This device is a manual, mechanical applicator, not an algorithm or software. The "performance" is demonstrated through nonclinical engineering tests.

7. Type of Ground Truth Used

The "ground truth" for the nonclinical tests was established by engineering specifications, recognized standards (like ISO-594-1), and design requirements derived from risk analysis. It does not involve expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm or a system that requires a "training set" for its development. Its performance is based on its mechanical design and materials.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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K102563

510(k) SUMMARY

DATE OF SUMMARY:	October 28, 2010
	MAR 15 2011
OWNER:	Micromedics, Inc.1270 Eagan Industrial Road, Ste. 120ST. Paul, MN 55121
CONTACT PERSON:	Tom LopacManager, Quality Assurance and Regulatory AffairsTelephone: 651-452-1977Fax: 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	Previous510(k)	ClearanceDate
Biomaterial Spray Syringe	Micromedics, Inc.	K982372	7-22-1998

DESCRIPTION OF THE DEVICE:

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.

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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 Syringe510(k) K982372 (exempt)
Intended use	The single Cannula ExtendedApplicator is intended for medicalpurposes to irrigate or instill fluids to awound or body cavity.	The Biomaterial Spray Syringe isintended for medical purposes to irrigateor instill fluids to a wound or bodycavity.
SystemComponents	1) Applicator instrument2) 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
Compatibilitywith otherdevices	1) Used with single standard medicalsyringe2) Fits into 5 mm endoscopic cannula	1) Used with single standard medicalsyringe
Materials	Stainless steelABS 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

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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

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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.

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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

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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)

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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Regulation Number and Section

§ 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.