The Misonix Irrigation System Model BC20P is indicated for use in the delivery of fluids in the following surgical specialties: General Surgical Procedures. The Misonix Irrigation System (BC20P) is not intended for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

Device Description

The Misonix Irrigation System (BC20P) is a liquid transfer system. It is designed to utilize standard or custom tubing sets, which mate to IV bottles or bags, open reservoirs or other liquid canisters. The liquid is drawn through the pump head and then pressurized, allowing the liquid to be transferred from the source. The outlet of the tube set may be connected to a cannula or other orifice to allow flushing and cleaning of the site. It can be used to refill small containers from a larger reservoir. It is not intended for drug delivery or the administration of parenteral fluids.

AI/ML Overview

The acceptance criteria and study proving the device meets them are detailed below, based on the provided 510(k) summary for the Misonix Irrigation System (Model BC20P).

This device, an irrigation system, is fundamentally different from a diagnostic AI device, therefore, many of the typical questions regarding AI/ML-based device evaluation (like human-in-the-loop studies, effect size of AI assistance, expert consensus for ground truth, and training data specifics) are not applicable. The evaluation focused on engineering performance and substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance

The provided document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail table as might be seen for a diagnostic device. Instead, the "acceptance criteria" are implicitly derived from the performance of the predicate device and Misonix's stated equivalence to it. The "reported device performance" is a confirmation that the Misonix Irrigation System (BC20P) meets the specifications and performs identically to the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Equivalence: Be identical in all aspects to the LySonix Irrigation System (K974233) regarding design and manufacturing specifications.	The Misonix Irrigation System is identical in all aspects to the LySonix Irrigation System since both units have been designed and manufactured to the same specifications by Misonix. (Section 6)
Output Power: Deliver specified output power (No Load to Maximum Load).	(Implied) Measurements were performed and found acceptable during "Output Power Measurements (No Load to Maximum Load)". Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9)
Irrigation Flowrate: Deliver specified irrigation flowrate.	(Implied) Measurements were performed and found acceptable during "Irrigation Flowrate Measurements". Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9)
Life Cycle: Demonstrate acceptable device longevity and durability.	(Implied) "Life Tests" were performed and found acceptable. Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9)
Vacuum Performance: Deliver specified vacuum flowrate and pressure.	(Implied) Measurements were performed and found acceptable during "Vacuum Flowrate and Pressure Measurements". Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9)
Input Power: Operate within specified input power parameters.	(Implied) Measurements were performed and found acceptable during "Input Power Measurements". Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9)
Electromagnetic Interference (EMI): Comply with EMI standards.	(Implied) "EMI Tests" were performed and found acceptable. Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9)
Electrical Safety (Dielectric Tests): Meet dielectric test requirements on mains and patient circuits.	(Implied) "Dielectric Tests on Mains Circuits" and "Dielectric Tests on Patient Circuits" were performed and found acceptable. Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9)
Electrical Safety (Patient Current Leakage): Meet patient current leakage and patient sink current limits.	(Implied) "Patient Current Leakage and Patient Sink Current Measurements" were performed and found acceptable. Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9)
Electrical Safety (Power Line Ground Leakage): Meet power line ground leakage limits.	(Implied) "Power Line Ground Leakage Measurements" were performed and found acceptable. Conclusion: Device is substantially equivalent to predicate based on operating characteristic specifications and Engineering Tests. (Section 7, 9)
Intended Use: Be suitable for fluid delivery in general surgical procedures, and not for drug delivery or parental fluids.	The device is indicated for use in the delivery of fluids in general surgical procedures. It is not intended for drug delivery or the administration of parenteral fluids. (Section 5, Indications for Use) This closely matches the predicate's implied intended use for an irrigation pump.
Environmental/Safety Compliance: Adhere to relevant voluntary consensus standards and hazard analysis.	"Voluntary Consensus Standard Investigations" and a "Hazard Analysis" were conducted. Conclusion: Device is substantially equivalent to predicate. (Section 9)

Summary of the Study Proving Acceptance:

The study proving the device meets the acceptance criteria is primarily a non-clinical engineering and comparison study. The core of the demonstration is proving substantial equivalence to the predicate LySonix Irrigation System (K974233). This involved:

Direct comparison: Stating that the Misonix system is "identical in all aspects" due to being designed and manufactured to the same specifications as the LySonix system.
Engineering Tests: A series of functional and safety tests were performed to confirm performance characteristics. These tests included:
- Output Power Measurements (No Load to Maximum Load)
- Irrigation Flowrate Measurements
- Life Tests
- Vacuum Flowrate and Pressure Measurements
- Input Power Measurements
- EMI Tests
- Dielectric Tests on Mains Circuits
- Patient Current Leakage and Patient Sink Current Measurements
- Power Line Ground Leakage Measurements
- Dielectric Tests on Patient Circuits
Analysis: An analysis of operating characteristic specifications, output of engineering tests, hazard analysis, and voluntary consensus standard investigations.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the summary for what appears to be a hardware device. The "test set" would refer to the physical units of the Misonix Irrigation System (Model BC20P) that underwent the engineering tests. Typically, for such devices, a small number of production or pre-production units are tested. The document does not specify the number of units tested or the provenance of the data beyond implying it was generated by Misonix.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable for this type of device. The "ground truth" for an irrigation pump is its physical performance characteristics (e.g., flow rate, power, safety parameters). These are measured directly through engineering tests, not established by expert consensus or interpretation as in medical imaging or diagnostic AI. The experts involved would be qualified engineers and technicians performing the tests and analysis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no subjective interpretation requiring adjudication. Performance is measured objectively.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This is not an AI/ML device, nor is it a diagnostic tool requiring human interpretation or a comparative effectiveness study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is not an AI/ML device. The device operates as a standalone irrigation pump.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used is objective engineering measurements and compliance with established specifications and safety standards, primarily benchmarks against the predicate device. It includes:

Physical measurements (e.g., power output, flow rate, vacuum pressure).
Electrical safety tests (e.g., dielectric tests, leakage current).
Durability (life tests).
Compliance with voluntary consensus standards.
The fact that it was "designed and manufactured to the same specifications" as the legally marketed predicate device.

8. The sample size for the training set

This is not applicable. This is a hardware device, not an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established

This is not applicable as there is no training set.

Summary

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510K SUMMARY - MISONIX IRRIGATION SYSTEM MODEL BC20P

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMSA 1990 and 21CFR 807.92.

The assigned 510(k) number is: K013417

Submitter's Identification 1.

Name:	MISONIX, INC.
Address:	1938 New Highway, Farmingdale, NY 11735
Telephone Number:	(516) 694-9555
Contact Person:	Ronald R. Manna
Date Prepared:	5 October 2001
Date Revised:	8 February 2002

2. Name of Device

Misonix Irrigation System (Model BC20P) Proprietary Name:

BC20P Common / Usual Name:

Classification Name: Pump, Irrigation

GBX Product Code:

3. Predicate Device Information

LySonix Irrigation System K974233 Predicate Device

4. Device Description:

પં Intended Use:

The Misonix Irrigation System Model BC20P is indicated for use in the delivery of fluids in the following surgical specialties:

General Surgical Procedures

6. Comparison to Predicate Device:

The Misonix Irrigation System is identical in all aspects to the LySonix Irrigation System since both units have been designed and manufactured to the same specifications by Misonix.

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Discussions of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:

Output Power Measurements (No Load to Maximum Load) Irrigation Flowrate Measurements Life Tests Vacuum Flowrate and Pressure Measurements Input Power Measurements EMI Tests Dielectric Tests on Mains Circuits Patient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits.

Discussions of Clinical Tests Performed 8.

N/A

9. Conclusions

Based upon an analysis of the operating characteristic specifications, Output of Engineering Tests, Hazard Analysis, Voluntary Consensus Standard Investigations and the designing activities, Misonix, Inc. has concluded that the Misonix Irrigation System is substantially equivalent to the LySonix Irrigation System.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2002

Misonix, Inc. Albert F. Clancy, Jr. Manager, QA/RA 1938 New Highway Farmingdale, New York 11735

Re: K013417

Trade Name: Misonix Irrigation System (Model BC20P) Regulation Number: 878.4200; 876.5220 Regulation Name: Introduction/Drainage Catheter and Accessories; Colonic Irrigation System Regulatory Class: II Product Code: GBX; KPL Dated: October 5, 2001 Received: October 15, 2001

Dear Mr. Clancy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

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.

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Page 2 - Mr. Albert Clancy

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, «Misbranding by reference to premarket notification» (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

A. Celia M. Witten, Ph.D., M.D.

Witten, Ph.D Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PREMARKET NOTIFICATION

INDICATIONS FOR USE

510k Number: K013417

Device Name: Misonix Irrigation System (Model BC20P)

Indications for Use/ Intended Use:

The Misonix Irrigation System Model BC20P is indicated for use in the delivery of fluids in the following surgical specialties: .

General Surgical Procedures

The Misonix Irrigation System (BC20P) is not intended for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restora
and Neurological Devices

510(k) Number	K012417
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Prescription Use (Per 21CRF 801.109)	✓
OR
Over the Counter Use

Regulation Number and Section

§ 878.4200 Introduction/drainage catheter and accessories.

(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(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 § 878.9.