(51 days)
The reusable guide is intended to provide physicians a tool for performing needle/instrument guided procedures with the use of the ultrasound endocavity transducer. The guide is attached over the endocavity transducer/probe/scanhead instruments. This device provides a fixed path for the needle or the instrument that when coupled by the ultrasound system software corresponds to on-screen imaging guidelines for visualizing guided instrument placement procedures. KOELIS endorectal ultrasound guides are supplied cleaned and are reusable.
The reusable guide is dedicated for transrectal diagnosis ultrasound needle /instrument guided procedure.
The reusable guide is designed to be clipped onto an ultrasonic endocavity probe, to guide a needle along the said probe, and to be cleaned and re-sterilized after use.
The provided text describes a 510(k) summary for a "Reusable Guide" manufactured by KOELIS. This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed clinical study data or acceptance criteria related to device performance in a clinical setting.
Therefore, many of the requested sections about acceptance criteria, detailed study designs, and performance metrics are not present in the provided text. The submission focuses on device characteristics, intended use, and materials to establish equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided as a formal table with acceptance criteria. The submission focuses on demonstrating substantial equivalence to a predicate device (CIVCO Transrectal Needle biopsy Guide, K875128/A) by comparing technological characteristics, intended use, and materials.
The 'Effectiveness' section states:
- "Both the subject and predicate devices are designed for secure and aligned fit to the transducer, while not altering the transducer design integrity or function."
- "Positive registration features of the design ensures accurate needle / instrument path and placement in relation with the transducer."
- "Exterior shapes of the guide are contoured for patient comfort with no sharp edges."
These statements describe design goals and anticipated performance, but not quantifiable acceptance criteria or reported device performance metrics from a formal study.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission does not describe a clinical study with a test set of data. It is a 510(k) summary focused on device design and comparison to a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No clinical study or ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable. No clinical study or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. No MRMC study or comparative effectiveness study involving human readers is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a mechanical guide, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. No ground truth for device performance is described. The submission relies on design specifications and material safety evaluations.
8. The Sample Size for the Training Set
Not applicable. No training set for an algorithm is relevant to this mechanical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No ground truth for a training set is relevant to this mechanical device.
Summary of available information related to performance and safety:
The submission focuses on inherent device characteristics and comparison to the predicate device to establish safety and effectiveness, rather than a quantifiable performance study against specific acceptance criteria.
- Intended Use & Indications for Use: The device is intended for "transrectal diagnosis ultrasound needle/instrument guided procedures."
- Design & Effectiveness (as stated):
- Secure and aligned fit to the transducer without altering its function.
- Positive registration features ensure accurate needle/instrument path and placement.
- Contoured exterior shapes for patient comfort with no sharp edges.
- Material Safety: The device uses Stainless steel (304, 316L, 17/4 PH). KOELIS conducted a biological safety evaluation based on risk analysis, literature data, and manufacturing process according to ISO10993-1. The report concluded adequate data to demonstrate biological safety. This is a critical aspect for a reusable device with limited body contact (intact skin/mucosal membranes, <24 hours).
- Cleaning and Sterilization: The device is supplied cleaned and is reusable, implying there are established cleaning and re-sterilization protocols (though these protocols themselves are not detailed in the provided excerpt).
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| Image: KOELIS logo | TRADITIONAL 510(K) | |
|---|---|---|
| 510(k) Number: UNKNOWN | Version: 1.0 | |
| Pr-Name: REUSABLE GUIDE | Date: 2014.05.12 |
5 510(K) SUMMARY OR 510(K) STATEMENT
510(k) Summary for REUSABLE GUIDE
The 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Owner | KOELIS5, avenue du Grand Sablon38700 La TroncheFRANCEPhone: +33 476 637 588 | Fax: +33 476 549.561 |
|---|---|---|
| Contact Name: | Mrs Laetitia GERVAISQuality ManagerMail: gervais@koelis.com | |
| Date Prepared | 2014.05.12 |
Proposed Device:
| Trade Name | Reusable guide |
|---|---|
| Common Name | Ultrasound transducer needle/instrument guide |
| Classification Name | Ultrasonic Diagnostic Transducer accessories |
| Device Class | II |
| Product Code | ITX |
Cleared Device:
The reusable guide is substantially equivalent to:
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|---|---|
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| 510(k) Number | |
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| K875128/AAN ANNAGER AND AN ALLAND A BOOK | fransrectal Needle biopsy Guide |
Intended Use:
The reusable guide is intended to provide physicians a tool for performing needle/instrument guided procedures with the use of the ultrasound endocavity transducer.
The guide is attached over the endocavity transducer/probe/scanhead instruments. This device provides a fixed path for the needle or the instrument that when coupled by the ultrasound system software corresponds to on-screen imaging guidelines for visualizing guided instrument placement procedures. KOELIS endorectal ultrasound guides are supplied cleaned and are reusable.
Traditional 510(k) FOR8302 QMS TITLE ID Page 8 of 31 KOEUS, 5 avenue du Grand Sablon 38700 La Tronche FRANCE. Tel +33 (0)476 637 587 yevy knelis com @KOELIS SAS, RCS Grenoble 492 218 375, 8 rue du Duployé 38100 Grenoble. Code APE 7112B
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| Image: logo | TRADITIONAL 510(K) | |
|---|---|---|
| K O E L I S | 510(k) Number: UNKNOWNPr-Name: REUSABLE GUIDE | Version: 1.0Date: 2014.05.12 |
Indications for Use:
The reusable guide is dedicated for transrectal diagnosis ultrasound needle /instrument guided procedure.
Device Description:
The reusable guide is designed to be clipped onto an ultrasonic endocavity probe, to guide a needle along the said probe, and to be cleaned and re-sterilized after use.
The intended use and the indication for use place the Koelis reusable guide in device body contact category as follow :
Surface devices, intact sin/mucosal membranes limited contact (<24hours)
Technological Characteristics compared with the cleared device:
| Company | KOELIS. | CIVCO |
|---|---|---|
| Device: | Reusable guide | Transrectal Needle biopsy Guide |
| 510(k) number | K875128/A | |
| Intended.Use | Both subject and predicate devices provide a mechanical means forperforming transrectal needle/instrument guided procedures with the use ofthe diagnostic ultrasound endocavity transducer.The devices provide a fixed path for the needle or instrument that whencoupled by the ultrasound system software corresponds to on-screen imagingguidelines for visualizing guided instrument placement procedures. | |
| Intended for transrectal procedures | Intended for transrectal procedures | |
| Design | Both subject and predicate devices include a linear tube with a stainless steelcannula attached external to the transducer at a fixed position. | |
| An entry cone to easily introduce theneedle into the tube | ||
| Fixation mechanism of the guide on the probe : | ||
| a clip welded on the tube, thatallows the stability of the guide onthe transducer and 2 fixing notches | a ring locks the guide around theprobe thanks to a lateral screw. |
Substantial Equivalence Comparison Chart
| A STATULAR AND STATE A LA LEAST CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTIONQMS TITLE | Comments of the control control and control control control a province a comments of consistence of the proposition of the program and consistence of the proposition of the pTraditional 510(k) | ID FOR8302 | Page 9 of 31 | ||
|---|---|---|---|---|---|
| 1 to management of the first of the first of the first of the first of the first and the many ofA Canada Career Station Comments of ChildrenKOEUS, 5 avenue du Grand Sablon 38700 La Tronche FRANCE. Tel +33 (0)476 637 587 www.knelis.com | |||||
| OKOEUS SAS. RCS Grenoble 492 218 375, 8 rue du Duployé 38100 Grenable. Code APE 71128 |
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K141334
Page 3 of 3
| TRADITIONAL 510(K) | ||||
|---|---|---|---|---|
| KOELIS | 510(k) Number: | UNKNOWN | Version: | 1.0 |
| Pr-Name: | REUSABLE GUIDE | Date: | 2014.05.12 |
| Company | KOELIS | CIVCO |
|---|---|---|
| Device | Reusable guide | Transrectal Needle biopsy Guide |
| 510(k) number | - | K875128/A |
| Material | Stainless steel 304Stainless steel 316LSteel 17/4 PHThese materials are widely used inmedical applications for implants andancillaries. | Stainless steel 304 |
| Safety | As these materials are widely used,Koelis conducted a biological safetyevaluation based on a risk-basedanalysis, the literature data andmanufacturing process usedaccording to ISO10993-1. Theassociated report concluded thatthese data were adequate todemonstrate the biological safety. | Biological safety has been evaluatedusing biocompatibility tests inaccordance with ISO 10993-1. Testinghas demonstrated t the biologicalsafety of the device |
| Effectiveness | Both the subject and predicate devices are designed for secure and aligned fitto the transducer, while not altering the transducer design integrity orfunction.Positive registration features of the design ensures accurate needle /instrument path and placement in relation with the transducer.Exterior shapes of the guide are contoured for patient comfort with no sharpedges. |
| IQMS TITLE | Commended on the Commend Comments of Concessionwhile and and the research and the commended to the commended to the commend ofTraditional 510(k) | Annual manufacturer and and and a bill be half the many and the comments of the comments of the may of the mayID FOR8302 | STATE FOR STATE A STATULAR STORE THE SECTION CONSULTION OF THE CONSULTION OF THE CONSTITUTION OF THE CONSTITUTION OF THE CONSTITUTION OF THE CONSTITUTION OF THE CONSTITUTIONPage 10 of 31 | ||||
|---|---|---|---|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------KOEUS 5 aunnue du Grand Sablon 38700 La Tronche ERANCE Tel +33 (0)476 637 587 www.knelis.com |
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KOEUS, 5 avenue du Grand Sablon 38700 La Tronche FRANCE. Tel +33 (0)+76 637 587 سیلاطویلندیو
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three thick, curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2014
KOELIS % LAETITIA GERVAIS QUALITY MANAGER 5 AVENUE DU GRAND SABLON LA TRONCHE 38700 FRANCE
Re: K141334
Trade/Device Name: Reusable Guide Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: July 1, 2014 Received: July 2, 2014
Dear Mrs. Gervais:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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-Mrs. Gervais
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (2) 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/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Aredrew D. O'Hara
l·or
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510{k} Number (if known) tinkmown K141334
Device Name REUSABLE GUIDE
Indications for Use (Describe)
The reusable guide is dedicated for transrectal diagnosis ultrasound needle finstrument guided procedure.
Type of Use (Select one or both. as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
This section applies only to requirements of the Paperwork Reduction Act of 1995,
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.