The ARTHRO-Pump PA304 is an arthroscopic pump intended to provide fluid distension of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid aspiration during diagnostic and operative arthroscopic procedures.

Device Description

The ARTHRO-Pump PA304 is a microprocessor controlled single roller pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump consists of the following main components: a power supply, a power switch, a touch display, a connection for the suction function, a roller wheel, a pump head and a casing. The pump has to be used with the following tube sets:

. Standard Irrigation Tube Set (also referred to as "ST261")
. Suction Tube Set (one connection, "I"-shape; also referred to as "ST287")
Suction Tube Set (two connections, "Y"-shape; also referred to as "ST282") .
Vacuum Tube Set (also referred to as "ST291"). .

AI/ML Overview

The provided text describes the 510(k) premarket notification for the ARTHRO-Pump PA304. This device is an arthroscopic pump, and the documentation focuses on demonstrating its substantial equivalence to a predicate device (Arthroscopy Pump A107) rather than providing detailed acceptance criteria and a study specifically designed to prove all aspects of its performance against those criteria in a typical clinical study format.

However, based on the provided information, I can infer the acceptance criteria and summarize the studies performed to demonstrate the device's safety and effectiveness for its intended use, focusing on the available performance data.

Here's an interpretation and structured presentation of the information:

Acceptance Criteria and Device Performance for ARTHRO-Pump PA304

The ARTHRO-Pump PA304 is an arthroscopic pump. The primary goal of the 510(k) submission is to demonstrate its substantial equivalence to a predicate device (Arthroscopy Pump A107) by showing that its performance does not raise new questions of safety and effectiveness. Therefore, the "acceptance criteria" are implicitly tied to meeting established safety and performance standards for arthroscopic pumps and showing comparable or superior performance to the predicate device where applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Inferred from testing)	Reported Device Performance
Software Performance:
- Adherence to medical device software standards.	- Software developed, tested, and verified in accordance with FDA guidance for software in medical devices and IEC62304:2006.
- Device performs as intended.	- Design verification testing demonstrates the device performs as intended, and performance does not raise new questions of safety and effectiveness.
Electrical Safety & EMC:
- Compliance with electrical safety and electromagnetic compatibility standards.	- Tested in accordance with AAMI ANSI ES60601-1: 2005/(R)2012 and IEC 60601-1-2:2014. (Implies compliance was achieved).
Biocompatibility (Tube Sets):
- Biocompatible materials for patient contact components (tube sets).	- Tested on tube sets in accordance with ISO 10993-1, -5, -10, and -11. (Implies satisfactory biocompatibility).
Sterilization (Tube Sets):
- Effective sterilization of tube sets.	- Sterilization validation performed according to ISO 11135-1:2015, ISO 14937:2009.
- Residual ethylene oxide and ethyle chlorohydrin within limits.	- Residual EO < 4 mg and ECH < 5 mg after 10 days of aeration.
- Sterility Assurance Level (SAL) meets standard.	- SAL was ≤ 10^-6.
- Package and product integrity maintained after sterilization and aging.	- Tested in accordance with ISO 11607-1 and ASTM-F-1980:2002. (Implies integrity was maintained).
Bench Performance (Pressure Regulation):
- Generation of stable pressure within a predefined range.	- Bench testing demonstrated that the ARTHRO-Pump PA304 generates a stable pressure in a predefined pressure range.
- Ability to compensate for pressure changes.	- Bench testing demonstrated the ability to compensate for changes in pressure.
Functional Equivalence to Predicate Device:
- Provides fluid distension and aspiration for arthroscopic procedures safely and effectively.	- "Based on the similar intended use, the same basic technological characteristics and performance testing, the ARTHRO-Pump PA304 is substantially equivalent to the predicate device Arthroscopy Pump A107 (K030402). The differences between the proposed device and the predicate device do not raise new questions of safety and effectiveness." This is the overarching conclusion of the 510(k) submission, supported by all the performed tests.

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

Software Design Verification: Not explicitly stated, but implies comprehensive testing according to standards.
Electrical Safety & EMC Testing: Not explicitly stated, typically involves testing representative units.
Biocompatibility Testing: Performed on "the tube sets of both the proposed device and predicate device." Specific number of samples not given, but standard practice involves multiple samples per test (e.g., cytotoxicity, irritation, sensitization, systemic toxicity).
Sterilization Validation: Performed on "the tube sets of both devices." Specific sample size not given, but validation processes typically involve statistically significant numbers of products run through the sterilization cycle to establish SAL and residual levels.
Bench Performance Testing: 36 test runs were conducted.
Data Provenance: The document refers to "The ARTHRO-Pump PA304 is designed, developed and manufactured by W.O.M. WORLD of MEDICINE GmbH" in Berlin, Germany. Therefore, the data would originate from their internal testing and validation processes. All testing appears to be retrospective bench-top and lab-based testing, performed to support the 510(k) submission, rather than prospective clinical trials.

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

This information is not applicable in the context of this 510(k) summary. The "ground truth" here is compliance with engineering standards and specific performance metrics (e.g., pressure stability, sterilization levels, biocompatibility). These are established through validated testing methodologies and adherence to international standards, not through expert clinical consensus on a test set of patient data.

4. Adjudication Method for the Test Set:

Not applicable. This pertains to clinical studies using human observers/experts. The tests described are laboratory-based engineering and safety validations.

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:

No, an MRMC study was not done. This type of study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation of medical images is involved. The ARTHRO-Pump PA304 is a surgical pump; its performance is assessed through its physical characteristics, fluid dynamics, safety, and compatibility, not human interpretation of data.

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

This question is phrased for AI/software algorithms. While the device does contain software, the "standalone" performance here refers to the pump's mechanical and fluidic operation and the correct execution of its programmed functions, which were evaluated through design verification and bench testing. The software itself was tested for compliance withIEC62304:2006. The pump's operation without human intervention (e.g., maintaining a set pressure) would be considered part of its standalone performance.

7. The type of ground truth used:

For this device, the "ground truth" is defined by:
- Engineering Specifications: The design parameters for pressure range, stability, fluid flow.
- International Standards: Compliance with ISO (e.g., 10993, 11135, 11607, 14937) and IEC (e.g., 60601) standards for medical devices, electrical safety, biocompatibility, and sterilization.
- Regulatory Guidance: Adherence to FDA guidance for software in medical devices.
- Predicate Device Performance: Implicitly, the performance of the legally marketed predicate device (Arthroscopy Pump A107) serves as a benchmark for comparison when demonstrating substantial equivalence.

8. The sample size for the training set:

Not applicable. This device is an arthroscopic surgical pump, not an AI/machine learning model that requires a training set. The software mentioned is likely control software for the physical pump functions, developed using standard software engineering practices rather than machine learning.

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

Not applicable. As stated above, there is no "training set" in the context of an AI/ML system for this device. The software was developed and verified against predefined functional requirements and engineering specifications to control the pump's operations.

Summary

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May 9, 2018

W.O.M. World of Medicine GmbH Soeren Markworth Head of Regulatory Affairs Salufer 8 10587 Berlin, Germany

Re: K173311

Trade/Device Name: ARTHRO-Pump PA304 Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: April 9, 2018 Received: April 12, 2018

Dear Soeren Markworth:

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, 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.

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K173311

Device Name

ARTHRO-Pump PA304

Indications for Use (Describe)

XJ Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

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510(k) SUMMARY OF SAFETY & EFFECTIVENESS

(Content in accordance with 21 CFR §807.92)

1. General Information

Submitter:	W.O.M. WORLD OF MEDICINE GmbH
	Salufer 8
	10587 Berlin
	Germany
Registration Number:	3001556604
Contact Person:	Dr. Soeren MarkworthHead of Regulatory Affairs
Date prepared:	Phone: +4930-399 81-594Fax: +4930-399 81-593E-mail: soeren.markworth@wom.group
Date prepared:	6th of April, 2018

2. Proposed Device

Trade Name:	ARTHRO-Pump PA304
Common Name:	Pump for Arthroscopy
Classification Name:	Arthroscope
Regulation Number:	21 C.F.R. § 888.1100
Regulatory Class:	II
Product Code:	HRX

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	K173311
ARTHRO-Pump PA304
510(k) Premarket Notification

3. Predicate Device

Trade Name:	Arthroscopy Pump A107
510(k) Number:	K030402
Classification Name	Arthroscope
Regulation Numer	21 C.F.R. § 888.1100
Regulatory Class	II
Product Code	HRX

4. Reference Device

Trade Name:	LAP-Pump PP110
510(k) Number:	K163320
Classification Name	Gynecologic laparoscope and accessories
Regulation Numer	21 C.F.R. § 884.1720
Regulatory Class	II
Product Code	HET

5. Device Description

. Standard Irrigation Tube Set (also referred to as "ST261")
. Suction Tube Set (one connection, "I"-shape; also referred to as "ST287")
Suction Tube Set (two connections, "Y"-shape; also referred to as "ST282") .
Vacuum Tube Set (also referred to as "ST291"). .

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6. Intended Use

The ARTHRO-Pump PA304 is an arthroscopic pump intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid aspiration during diagnostic and operative arthroscopic procedures.

7. Comparison of Technological Characteristics

The Arthroscopy Pump A107 is the predicate device for the ARTHRO-Pump PA304. Both pumps are designed, developed and manufactured by W.O.M. WORLD of MEDICINE GmbH. They have the same intended use and incorporate the same basic design. Specifically, both the ARTHRO-Pump PA304 and the Arthroscopy Pump A107 are pumps for use during arthroscopic procedures to provide fluid irrigation and aspiration. They are both roller pumps that function according to the peristaltic principle and are to be used with specially designed tube sets.

The differences in the technological characteristics of both the proposed device ARTHRO-Pump PA304 and the predicate device Arthroscopy Pump A107 are minor and do not raise new questions of safety and effectiveness. The main differences between both devices are the following:

· The suction function is achieved by different technological means. The ARTHRO-Pump PA304 is a pump with one roller wheel for irrigation and incorporates a suction pump in order to provide fluid aspiration. The Arthroscopy Pump A107 has two roller wheels, one for irrigation and one for aspiration. Both the suction pump of the proposed device and the second roller wheel of the predicate device have the same function, which is to provide negative pressure on the outflow side of the arthroscope.
. The ARTHRO-Pump PA304 is designed with a radio frequency identification (RFID) transponder technology tube set recognition function that controls the proper position of the Inflow Tube Set and eliminates accidental reuse of an inflow tube set by invalidating the tube set after the irrigation process has been started.

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The ARTHRO-Pump PA304 is designed with a touch sensitive display and offers . presets for knee, hip, shoulder or small joints arthroscopies.
. Finally, the ARTHRO-Pump PA304 incorporates only one pressure sensor in place of the redundant pressure measurement of the Arthroscopy Pump A107.

8. Performance Data

Software

The software was developed, tested, and verified in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and in accordance with the following standard:

. IEC62304:2006 - Medical Device Software - Software Life Cycle Processes.
Design verification testing of the ARTHRO-Pump PA304 demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness.

Electrical safety and electromagnetic compatibility

Electrical safety and electromagnetic compatibility testing was performed in accordance to the below standards:

. AAMI ANSI ES60601-1: 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General Requirements . for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances - Requirements and Tests;

Biocompatibility

Biocompatibility testing was performed on the tube sets of both the proposed device and predicate device in accordance with:

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Image /page/7/Picture/1 description: The image shows the logo for WOM, which is a medical device company. Below the logo is the text "ARTHRO-Pump PA304". The text "510(k) Premarket Notification" is below the model number. The logo is a circle with a stylized shape inside, with the bottom portion of the shape colored in pink.

. ISO 10993-1 - Biological evaluation of medical devices- Evaluation and testing within a risk management system;
. ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity; and
. ISO 10993-10 - Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization;
. ISO 10993-11 - Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity.

Sterilization

In addition, sterilization validation on the tube sets of both devices has been performed in accordance with:

· ISO 11135-1:2015 Sterilization of health care products Ethylene oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
ISO 14937:2009 Sterilization of health care products General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; and
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals.

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 4 mg and ECH < 5 mg after 10 days of aeration (gas release) that remain on the tube set will not be exceeded. The sterility assurance level (SAL) was ≤ 10t%. Package and product integrity of the tube sets were tested in accordance with ISO11607-1 - Packaging for terminally sterilized medical devices and ASTM-F- 1980:2002 - Standard for accelerated aging of sterile medical device packages.

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Performance Testing - Bench

Finally, bench testing was performed to demonstrate that the proposed device ARTHRO-Pump PA304 is safe and effective. In total 36 test runs have been conducted. The test results demonstrate that the ARTHRO-Pump PA304 generates a stable pressure in a predefined pressure range and to compensate for changes in pressure.

9. Conclusion

Based on the similar intended use, the same basic technological characteristics and performance testing, the ARTHRO-Pump PA304 is substantially equivalent to the predicate device Arthroscopy Pump A107 (K030402). The differences between the proposed device and the predicate device do not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.