(203 days)
No
The description focuses on a microprocessor-controlled peristaltic pump for fluid management during arthroscopic procedures. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications.
No
The device is an arthroscopic pump that maintains fluid distension and aspirates fluid during arthroscopic procedures. It is a tool used in a therapeutic procedure, but it does not directly treat or diagnose a disease itself.
No
The device is an arthroscopic pump that manages fluid distension and aspiration during arthroscopic procedures. While these procedures can be for both diagnostic and operative purposes, the pump itself does not perform any diagnostic function (i.e., it does not identify or analyze a medical condition). Its role is purely assistive in maintaining the surgical field.
No
The device description clearly outlines hardware components such as a power supply, touch display, roller wheel, pump head, and casing, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the ARTHRO-Pump PA304 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing fluid distension and aspiration during diagnostic and operative arthroscopic procedures. This is a surgical/procedural device used directly on the patient's body, not for examining specimens in vitro (outside the body).
- Device Description: The description details a pump that transports fluid to and from joint cavities. This aligns with a surgical irrigation and aspiration system, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the ARTHRO-Pump PA304 is a surgical device used in arthroscopic procedures, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
HRX
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"). .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, hip, elbow, ankle and wrist joint cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Performance Data includes:
Software: 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 IEC62304:2006.
Electrical safety and electromagnetic compatibility: tested in accordance to AAMI ANSI ES60601-1: 2005/(R)2012 and IEC 60601-1-2:2014.
Biocompatibility: performed on the tube sets in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11.
Sterilization: validation on the tube sets performed in accordance with ISO 11135-1:2015, ISO 14937:2009, and ISO 10993-7:2008. Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO
§ 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.
0
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
1
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)
Device Name
ARTHRO-Pump PA304
Indications for Use (Describe)
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.
| XJ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
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| time to review instructions, search existing data sources, gather and maintain the data needed and complete | ||
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Type of Use (Select one or both, as applicable)
3
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 Markworth |
| Head of Regulatory Affairs | |
| Date prepared: | Phone: +4930-399 81-594 |
| Fax: +4930-399 81-593 | |
| E-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
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"). .
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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.
6
- 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