SOPRO 670 ARTHROSCOPIC PUMP

• K Number: K080122
• Device Name: SOPRO 670 ARTHROSCOPIC PUMP
• Manufacturer: SOPRO
• Date Cleared: 2008-07-11 ( 176 days)
• Product Code: HRX
• Regulation Number: 888.1100
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K954465
• Predicate For: N/A

Intended Use

The SOPRO 670 irrigation pump is a arthroscopic pump system intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures that may only be used by qualified physicians

Device Description

The SOPR0 670 irrigation pump is a peristaltic pump system designed to automatically provide and control distension and irrigation of the operative site during arthroscopic procedures and fluid irrigation of the operative site during laparoscopic procedures using sterile fluids. The pump is used in conjunction with specific tubing sets designed for arthroscopic procedures.
The Arthroscopy Pump SOPRO 670 is a microprocessor controlled pump system designed to provide liquid distension and irrigation of joint cavities and aspiration of liquids out of the joint cavities during diagnostic and operative arthroscopy. The Arthroscopy SOPRO 670 consists of the following main components: housing, power supply, roller wheel, pump head, a servo-motor, various setting keys and display elements. The device is to be used with special designed irrigation and suction tubings and a foot-remote control. A constant performed redundant pressure measurement controls the conformity of the actual pressure in the joint cavity with the pre-set nominal pressure.

AI/ML Overview

The provided text describes a 510(k) summary for the SOPRO 670 Arthroscopic Pump, focusing on its substantial equivalence to a predicate device rather than a de novo clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested elements for a study proving acceptance criteria cannot be directly extracted from this document, as this type of submission relies on demonstrating similarity to an already cleared device.

However, based on the information provided, here's what can be inferred or stated about the acceptance criteria and the "study" (in this context, the declaration of compliance and substantial equivalence):

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SOPRO 670 Arthroscopic Pump are implicitly based on its substantial equivalence to the predicate device, the Future Medical Systems FMS DUO (K954465), and compliance with relevant safety standards.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Intended Use	The device must be intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle, and wrist joint cavities, and fluid suction during diagnostic and operative arthroscopic procedures, for use by qualified physicians.	The SOPRO 670 Arthroscopic Pump's intended use fully matches this criterion. It is "intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures that may only be used by qualified physicians." This is explicitly stated to be shared with the predicate device.
Design and TechnicalCharacteristics	The device's design and technical characteristics should be similar to the predicate device to ensure similar safety and effectiveness.	The document states, "the device described in this notification is similar in design and technical characteristics to the Arthroscopic pump of the predicate device." It also highlights that "Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPRO 670 Arthroscopic Pump." The device is described as a "peristaltic pump system designed to automatically provide and control distension and irrigation... and fluid irrigation... using sterile fluids," and uses "specific tubing sets." It is a "microprocessor controlled pump system designed to provide liquid distension and irrigation of joint cavities and aspiration of liquids out of the joint cavities" with a "constant performed redundant pressure measurement controls the conformity of the actual pressure in the joint cavity with the pre-set nominal pressure."
Electrical Safety	Compliance with relevant international and national electrical safety standards.	The device "complies with the International Standard IEC 601-1 (Electrical Safety)." Additionally, it "meets the requirements of the Underwriter Laboratories Standard UL60601-1 and bears the CE mark in accordance with the Medical Device Directive 93/42/EEC."
Substantial Equivalence	The device must be demonstrated to be substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and the same or similar technological characteristics as the predicate device, and any differences in technological characteristics do not raise different questions of safety and effectiveness. (This is the overarching acceptance criterion for a 510(k)).	The FDA concluded, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." The submission explicitly states, "The SOPRO 670 Arthroscopic Pump is substantially equivalent to the arthroscopic pump functions of the predicate device by Future Medical Systems, arthroscopic pump and shaver model FMS DUO (K954465) previously cleared by the FDA and currently marketed." The submission provided a table comparing the device to the predicate.

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Regarding the study proving the device meets the acceptance criteria:

The "study" in this context is the 510(k) submission itself, which primarily relies on a comparative analysis and declarations of compliance with recognized standards, rather than a new clinical trial or performance study generating novel data.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. No specific test set of patients or data from a prospective study is mentioned for evaluating the performance of the SOPRO 670 Arthroscopic Pump against a predefined acceptance criterion in vivo. The submission relies on the established safety and effectiveness of the predicate device and the new device's compliance with engineering standards.
   • Data Provenance: Not applicable for a clinical test set from this document. The data provenance is primarily from engineering tests to ensure compliance with standards (IEC 601-1, UL60601-1) and comparison with the specifications of the predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. As there's no clinical test set for ground truth establishment in this type of submission, no experts were used in this manner. The ground truth for regulatory clearance in a 510(k) is the established safety and effectiveness of the predicate device and the compliance with recognized standards by the new device.

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

   • Not applicable, as there was no test set requiring multi-reader adjudication.

4. 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. This is a medical device (an arthroscopic pump), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI performance metrics are not relevant or performed for this submission.

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

   • Not applicable, as this is a medical device (pump) and not an algorithm or AI. The device operates as intended by a qualified physician.

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

   • The "ground truth" for regulatory clearance of the SOPRO 670 Arthroscopic Pump, in the context of this 510(k) submission, is based on:
     • Predicate Device Performance: The established safety and effectiveness of the FMS DUO (K954465).
     • Compliance with Recognized Standards: Verification through engineering testing and documentation that the SOPRO 670 meets standards such as IEC 601-1 and UL60601-1.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the machine learning sense for this medical device submission. The device's design and engineering are based on established principles of peristaltic pumps and medical device safety/performance.

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

   • Not applicable, as there is no training set for this device.

Summary

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10. Summary of Safety and Effectiveness - "510 (k) Summary"

A. Submitter Information SOPRO JUL 1 1 2008 ZAC Athélia IV Avenue des Genévriers 13705 La Ciotat Cedex FRANCE Telephone: [phone] Fax: [phone] Contact Person: Steve Salesky SOPRO c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel. NJ 08054 Tel: [phone] Fax: [phone] E-mail: [e-mail] Date Prepared: January 11, 2008 B. Device Identification Classification Name: Arthroscope and Accessories Common Usual Name: Arthroscopic Pump

Common Sample Name: Form Sample Strip

Proprietary Name: SOPRO 670 Arthroscopic Pump

C. Identification of Predicate Device

Device	Applicant	510(k) No.	Date Cleared
Future MedicalSystems FMS DUO	Future MedicalSystems	K954465	Nov. 9, 1995

The SOPRO 670 Arthroscopic Pump is substantially equivalent to the arthroscopic pump functions of the predicate device by Future Medical Systems, arthroscopic pump and shaver model FMS DUO (K954465) previously cleared by the FDA and currently marketed.

D. Device Description

The SOPR0 670 irrigation pump is a peristaltic pump system designed to automatically provide and control distension and irrigation of the operative site during arthroscopic procedures and fluid irrigation of the operative site during laparoscopic procedures using sterile fluids. The pump is used in conjunction with specific tubing sets designed for arthroscopic procedures.

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• 1080122
  The Arthroscopy Pump SOPRO 670 is a microprocessor controlled pump system designed to provide liquid distension and irrigation of joint cavities and aspiration of liquids out of the joint cavities during diagnostic and operative arthroscopy. The Arthroscopy SOPRO 670 consists of the following main components: housing, power supply, roller wheel, pump head, a servo-motor, various setting keys and display elements. The device is to be used with special designed irrigation and suction tubings and a foot-remote control. A constant performed redundant pressure measurement controls the conformity of the actual pressure in the joint cavity with the pre-set nominal pressure.

E. Intended Use

The SOPRO 670 irrigation pump is an arthroscopic pump system intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures that may only be used by qualified physicians.

F. Substantial Equivalence

The SOPRO 670 is substantially equivalent to the Arthroscopic pump functions of the predicate device by Future Medical Systems, Arthroscopy Pump and Shaver Model FMS DUO (K954465) previously cleared by the FDA and currently marketed. Both the Arthroscopy Pump SOPRO 670 and the predicate device are intended to provide fluid distension and irrigation of knee, shoulder, elbow, hip, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.

Furthermore, the Arthroscopy Pump SOPRO 670 and the predicate device FMS DUO (K954465) are both intended to provide fluid suction during arthroscopic procedures. In addition, the device described in this notification is similar in design and technical characteristics to the Arthroscopic pump of the predicate device.

Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPRO 670 Arthroscopic Pump.

G. Performance Data

The device complies with the International Standard IEC 601-1 (Electrical Safety) .In addition, the device meets the requirements of the Underwriter Laboratories Standard UL60601-1 and bears the CE mark in accordance with the Medical Device Directive 93/42/EEC.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SOPRO % ACTEON, Inc. Mr. Steve Salesky 124 Gaither Drive, Suite 140 Mt. Laurel, New Jersey 08054

JUL 11 2008

Re: K080122

Trade/Device Name: SOPRP 670 Arthroscopic Pump Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: June 6, 2008 Received: June 9, 2008

Dear Mr. Salesky:

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.

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. Steve Salesky

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Wilkinson

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

SOPRO 670 Arthroscopic Pump Device Name:

Indications for Use:

The SOPRO 670 irrigation pump is a arthroscopic pump system intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures that may only be used by qualified physicians

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(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, Restorative, and Neurological Devices

510(k) Number korap

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.