(15 days)
The Davol® ArthroVent™ Outflow Tubing is designed to control the amount of suction during arthroscopic procedures by controlling the amount of ambient air entering the outflow tubing set. It is for use with Davol's HydroFlex-AD Arthroscopic Distention System (reference 0025800, 0025200, 0025210), Arthro-Flo High Flow Irrigator (reference 0015000), and Gravity In-Flow Tubing Sets (reference 0088220, 0088240, and 0037870).
The proposed Davol® ArthroVent™ Outflow Tubing allows the user to regulate suction during arthroscopic procedures. It consists of two flexible suction connectors, flexible polyvinyl chloride (PVC) inlet and outlet tubes, and a suction regulator assembly. The variable control suction regulator assembly contains a one-way flapper valve, kidneyshaped main vent hole and secondary air channels. The secondary channels provide an alternate airflow path if the main vent were inadvertently obstructed. When the main vent is open, the suction regulator assembly allows ambient air into the system to reduce suction delivered to the operative site. As a user convenience, the outlet tube has a pinch clamp to close off suction.
This document describes the Davol® ArthroVent™ Outflow Tubing, an arthroscopic accessory designed to regulate suction during arthroscopic procedures. The provided text contains limited information regarding definitive acceptance criteria, and specific details about a formal study proving acceptance. However, based on the Performance Data section, we can infer the acceptance approach.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: Compliance with ISO 10993-1 requirements. | "The proposed ArthroVent Outflow Tubing will be compliant to the biocompability requirements pursuant to ISO 10993-1." (This is a statement of intent/expected compliance rather than a direct report of test results, but it implies this was an acceptance criterion). |
| Functional Equivalence: Performance similar to the predicate device (Stryker Suction Regulator) in regulating suction during arthroscopic procedures. This implies: a. Effective control of ambient air entry to modify suction. b. Functionality with specified inflow products (Davol's HydroFlex®-AD Arthroscopic Distention System, Arthro-Flo® High Flow Irrigator, and Gravity In-Flow Tubing Sets). | "Bench testing was performed to evaluate and compare the performance of the ArthroVent Outflow Tubing to the Stryker Suction Regulator using a simulated knee model and currently marketed inflow products. Results for both products were similar, which supports the substantial equivalence determination." (This broadly states performance parity, implying it met the functional equivalence criterion). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing" using "a simulated knee model" and "currently marketed inflow products." However, it does not specify:
- The exact sample size (number of devices tested, number of runs, etc.) for the bench tests.
- The data provenance (e.g., country of origin, retrospective or prospective). This was a bench test, so geographical origin for "data" is less relevant than for clinical data, but the specifics of the test setup are missing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not provide any information about experts being used to establish a "ground truth" for the test set. The study described is a bench test comparing performance to a predicate, not a clinical trial requiring expert interpretation of results for ground truth.
4. Adjudication Method for the Test Set
- Given that the study was a bench test comparing performance metrics, an adjudication method in the context of clinical interpretation (like 2+1 or 3+1 for expert consensus) is not applicable and therefore not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not conducted. The document describes a bench test, not a study involving human readers or clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a mechanical arthroscopic tubing product, not an AI algorithm or software. The "performance" being evaluated is the physical function of the tubing in regulating suction.
7. The Type of Ground Truth Used
- For the bench testing described, the "ground truth" would be objective physical measurements of characteristics like suction level, flow rate, or pressure generated/regulated, as compared to the predicate device. It's not expert consensus, pathology, or outcomes data in the usual medical device sense. The document states "Results for both products were similar," implying quantitative comparisons were made against predefined performance characteristics or established functional ranges.
8. The Sample Size for the Training Set
- This question is not applicable. The device is a physical medical device, not an AI model requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no training set for this device.
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K030307 1/2
of C. R. Harr ossett Cross ranston. RI 02920 401 463-7000
FEB 1 3 2003
Image /page/0/Picture/3 description: The image shows a logo with the word "DAVOL" in the center. The word is written in a simple, sans-serif font. The word is enclosed in a white oval shape. The oval is surrounded by a thick, black border that follows the shape of the oval.
510(k) Summary of Safety and Effectiveness Information
A. Submitter Information:
| Submitter's Name: | Davol Inc. |
|---|---|
| Address: | 100 Sockanossett CrossroadCranston, Rhode Island 02920 |
| Phone Number: | (401) 463-7000, Ext. 2386 |
| Fax Number: | (401) 463-3845 |
| Contact Person: | Lucinda L. Fox |
| Date of Preparation: | December 13, 2002 |
B. Device Name:
| Trade Name: | Davol® ArthroVent™™ Outflow Tubing |
|---|---|
| Common/Usual Name: | Arthroscopic Accessory |
| Classification Name: | Arthroscopic Accessory |
். Predicate Product:
Stryker Suction Regulator (K963648)
D. Device Description:
The proposed Davol® ArthroVent™ Outflow Tubing allows the user to regulate suction during arthroscopic procedures. It consists of two flexible suction connectors, flexible polyvinyl chloride (PVC) inlet and outlet tubes, and a suction regulator assembly. The variable control suction regulator assembly contains a one-way flapper valve, kidneyshaped main vent hole and secondary air channels. The secondary channels provide an alternate airflow path if the main vent were inadvertently obstructed. When the main vent is open, the suction regulator assembly allows ambient air into the system to reduce suction delivered to the operative site. As a user convenience, the outlet tube has a pinch clamp to close off suction.
Image /page/0/Picture/13 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be outlined in black. The font style is consistent throughout the word, giving it a uniform and recognizable appearance.
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E. Intended Use:
The Davol ArthroVent Outflow Tubing is designed to control the amount of suction during arthroscopic procedures by controlling the amount of ambient air entering the tubing set. It is for use with Davol's HydroFlex®-AD Arthroscopic Distention System (reference 0025800, 0025200, 0025210), Arthro-Flo® High Flow Irrigator (reference 0015000), and Gravity In-Flow Tubing Sets (reference 0088220, 0088240, and 0037870).
F. Summary of Similarities and Differences in Technological Characteristics, Performance, and Intended Use:
The ArthroVent Outflow Tubing and Stryker Suction Regulator are both designed to regulate suction by controlling the amount of ambient air entering the tubing sets. Both contain suction adapters, inlet and outlet tubes, and suction regulator mechanisms. Both products are made from similar materials and are sterile/single use devices. The main difference between the ArthroVent Outflow Tubing and the Stryker Suction Regulator concerns the suction regulator mechanisms. The ArthroVent Outflow Tubing has a variable control suction regulator assembly with a kidney shaped vent and one-way flapper valve while the Stryker Suction Regulator has a tear drop shaped vent with a 7 setting, thumb controlled slide without a valve. Also, the ArthroVent Outflow Tubing has a strainer inside the suction requlator assembly to prevent clogging and a pinch clamp on the outlet tube to close off suction. Finally, the ArthroVent Outflow Tubing is limited to arthroscopic use while the Stryker Suction Regulator may be used in any procedure where suction control is desired.
G. Performance Data:
As with the Stryker Suction Regulator, the proposed ArthroVent Outflow Tubing will be compliant to the biocompability requirements pursuant to ISO 10993-1. Bench testing was performed to evaluate and compare the performance of the ArthroVent Outflow Tubing to the Stryker Suction Regulator using a simulated knee model and currently marketed inflow products. Results for both products were similar, which supports the substantial equivalence determination.
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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 & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2003
Davol, Inc. c/o Ms. Michelle Weidman Office Assistant Coordinator Kema Medical 4377 County Line Road Chalfont, Pennsylvania 18914
Re: K030307
Trade/Device Name: ArthroVent Outflow Tubing Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: January 28, 2003 Received: January 29, 2003
Dear Ms. Weidman:
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 (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.
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Page 2 - Ms. Michelle Weidman
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 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) you may obtain. 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,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number: | Unknown |
|---|---|
| Device Name: | Davol® ArthroVent TM Outflow Tubing |
| Indications for Use: |
The Davol® ArthroVent™ Outflow Tubing is designed to control the amount of suction during arthroscopic procedures by controlling the amount of ambient air entering the outflow tubing set. It is for use with Davol's HydroFlex-AD Arthroscopic Distention System (reference 0025800, 0025200, 0025210), Arthro-Flo High Flow Irrigator (reference 0015000), and Gravity In-Flow Tubing Sets (reference 0088220, 0088240, and 0037870).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriame C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030307
Prescription Use (Per 21 CFR 801.109)
Or
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.