(116 days)
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are indicated for diagnosis and treatment for ultrasound-guided interventions.
-
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range)
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are indicated for guiding needles during ultrasound-guided interventions for diagnosis and treatment. -
a. CON-LEAD range and LIN-LEAD range
The guides from CON-LEAD range and LIN-LEAD range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment. -
b. PERINE range
The guides from the PERINE range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment on adult males. -
Steady Pro range
The Steady Pro range provides physician a tool for performing ultrasound-guided interventions with the use of an endocavity ultrasound transducer for adult males requiring prostate biopsy mapping and cancer treatment.
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are intended to provide a fixed path for needle insertion during ultrasound-guided interventions. The path is aligned with the ultrasound scan plane for needle imaging during the procedure. The ultrasound system can visualize the prospective path (as an on-screen guideline) in the ultrasound image to help needle positioning.
CON-LEAD range and LIN-LEAD range: The guides have an attachment system in which a perforated part is attached in order to place a needle. It is a system with removable parts (nails) to adapt to the different diameters of needles. The guides shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices. It is delivered cleaned but not sterile.
PERINE range: The guides have an attachment system in which a perforated part is attached in order to place a needle. For some applications, there is a system with removable parts (nails) to adapt to the different diameters of needles. There is a possibility to have a fix or a movable system depending on the guide chosen. The guides shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices. It is delivered cleaned but not sterile.
Steady Pro range: The Steady Pro range is a system which holds a 2D/3D lateral-fire endocavitary or 2D/3D endfire endocavitary ultrasound probe. It is an accessory of KOELIS systems. The main functions are to move the probe freely inside the working space of the probe holder in unlocked state, to maintain the probe in a specific position for an extended time when locked, to provide 6 degrees of freedom (rotation + translation) for arm and probe positioning, easy to use, sterilizable and cleanable, easy to cover and protect.
The provided text is a 510(k) summary for Koelis' reusable guides, specifically the PERINE range, NAIL range, CON-LEAD range, LIN-LEAD range, and the STEADY PRO range. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, test reports, or specific study designs with detailed performance metrics.
Therefore, many of the requested items cannot be extracted directly from this document. However, I can still provide information based on what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that "Verification and validation were performed to ensure that devices meet requirements" for the CON-LEAD, LIN-LEAD, and PERINE ranges, and "The design ensures accurate holding of the transducer. Verification and validation were performed to ensure that devices meet requirements" for the Steady Pro range. However, it does not specify what these requirements or acceptance criteria were, nor does it provide quantitative performance data. The device's primary function is guiding needles or holding an ultrasound probe, implying accuracy and stability as key performance indicators, but no specific metrics are given.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Verification and validation were performed to ensure that devices meet requirements." (for all ranges) |
| Not specified | "The design ensures accurate needle path and placement in relation with the transducer." (for CON-LEAD, LIN-LEAD, PERINE ranges) |
| Not specified | "The design ensures accurate holding of the transducer." (for STEADY PRO range) |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "The subject of this premarket submission did not require clinical studies to support substantial equivalence." This means there was no "test set" in the context of clinical performance evaluation with human data. The "tests" performed were non-clinical (biocompatibility, cleaning, disinfection effectiveness, and compliance with safety standards). No sample sizes or data provenance for these non-clinical tests are provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical studies were performed and thus no "test set" with ground truth from human data was established, this information is not applicable and not available in the provided document.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No MRMC study was mentioned. The submission states that no clinical studies were required.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
Not applicable as this is not an AI/algorithm-based device. It is a physical guide and holder for medical procedures.
7. The Type of Ground Truth Used:
For the non-clinical tests (biocompatibility, cleaning, disinfection effectiveness, and safety standards compliance), the "ground truth" would be established by the specifications defined in relevant international and national standards and regulations. The document states that the devices were "found to be compliant with applicable medical device safety standards" and "comply with voluntary standards," implying that these standards served as the basis for evaluation.
8. The Sample Size for the Training Set:
Not applicable, as this is not an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
{0}------------------------------------------------
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2017
KOELIS % Mrs. Laetitia Gervais Ouality and Regulatory Affairs Manager 16. chemin du vieux chene 38240 Meylan FRANCE
Re: K171040
Trade/Device Name: Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: July 11, 2017 Received: July 14, 2017
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
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{1}------------------------------------------------
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.
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" (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.
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/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K171040 |
|---|---|
| Device Name | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range |
| Indications for Use (Describe) | The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are indicated for diagnosis and treatment for ultrasound-guided interventions. |
- Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range)
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are indicated for
guiding needles during ultrasound-guided interventions for diagnosis and treatment.
- a. CON-LEAD range and LIN-LEAD range
The guides from CON-LEAD range and LIN-LEAD range are indicated for guiding needles during percutaneous
ultrasound-guided interventions for diagnosis and treatment.
- b. PERINE range
The guides from the PERINE range are indicated for guiding needles during percutaneous ultrasound-guided interventions
for diagnosis and treatment on adult males.
- Steady Pro range
The Steady Pro range provides physician a tool for performing ultrasound-guided interventions with the use of an
endocavity ultrasound transducer for adult males requiring prostate biopsy mapping and cancer treatment.
| 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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
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Image /page/3/Picture/0 description: The image contains the logo for KOELIS. The logo consists of a blue square with a yellow curved line running through it. To the right of the logo is the company name, "KOELIS", in blue sans-serif font.
| TRADITIONAL 510(K) | |||||
|---|---|---|---|---|---|
| 510(k) Number: | Version: 1.0 | ||||
| Pr-Name: | Date: | 2017.07.10 |
510(K) SUMMARY OR 510(K) STATEMENT
510(k) Summary
The 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Owner | KOELIS16, chemin du vieux Chêne38240 MeylanFRANCEPhone : +33 458 176 810Fax : +33 458 176 824 |
|---|---|
| Contact Name: | Ms Laetitia GERVAISQuality and Regulatory Affairs ManagerMail : gervais@koelis.comPhone : +33 458 176 811Fax : +33 458 176 824 |
| Date Prepared | 2017.07.10 |
Proposed Device:
| Trade Name | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range |
|---|---|
| Common Name | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range |
| Classification Name | Diagnostic Ultrasonic Transducer |
| Device Class | II |
| Product Code | ITX |
Cleared Device:
The devices of the reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are substantially equivalent to:
| 510(k) Number | Device Name |
|---|---|
| K093713 | Ultrasound General Purpose Guidance System |
| K131161 | AccuCARE™ product line |
Intended Use:
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are intended to provide a fixed path for needle insertion during ultrasound-guided interventions. The path is aligned with the ultrasound scan plane for needle imaging during the procedure. The ultrasound system can visualize the prospective path (as an on-screen guideline) in the ultrasound image to help needle positioning.
| TITLE | 510(k) Summary | ID | K171040 | Page 1 of 9 |
|---|---|---|---|---|
| ------- | ---------------- | ---- | --------- | ------------- |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for KOELN. The logo consists of a blue square with a yellow "K" shape inside of it. The text "KOELN" is written in blue, to the right of the square.
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range)
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are intended to provide a fixed path for needle insertion during ultrasound-guided interventions. The path is aligned with the ultrasound scan plane for needle imaging during the procedure. The ultrasound system can visualize the prospective path (as an on-screen guideline) in the ultrasound image to help needle positioning.
CON-LEAD range and LIN-LEAD range
The guides from CON-LEAD range and LIN-LEAD range are intended to guide a needle during ultrasound-guided interventions.
PERINE range
The guides from the PERINE range are intended to guide a needle during ultrasound-guided interventions.
Steady Pro range
The Steady Pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultrasound-guided interventions. Typical applications are biopsy or cancer treatment.
Indications for Use:
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are indicated for diagnosis and treatment for ultrasound-guided interventions.
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range)
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are indicated for guiding needles during ultrasound-guided interventions for diagnosis and treatment.
CON-LEAD range and LIN-LEAD range
The guides from CON-LEAD range and LIN-LEAD range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment.
PERINE range
The guides from the PERINE range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment on adult males.
Steady Pro range
The STEADY PRO range provides physician a tool for performing ultrasound-guided interventions with the use of an endocavity ultrasound transducer for adult males requiring prostate biopsy mapping and cancer treatment.
| TITLE | 510(k) Summary | ID | K171040 | Page 2 of |
|---|---|---|---|---|
| ------- | ---------------- | ---- | --------- | ----------- |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows a logo with a blue square tilted at an angle on the left side. Two yellow curved lines intersect the square, forming a stylized "K". To the right of the logo are the letters "KOE" in blue. The letters are in a simple, sans-serif font and are spaced evenly apart.
| TRADITIONAL 510(K) | ||
|---|---|---|
| 510(k) Number: | K171040 | Version |
| Pr-Name: | - | Date: |
1.0
2017.07.10
Device Description:
CON-LEAD range and LIN-LEAD range
The guides from CON-LEAD range and LIN-LEAD range have an attachment system in which a perforated part is attached in order to place a needle. It is a system with removable parts (nails) to adapt to the different diameters of needles.
The guides from CON-LEAD range and LIN-LEAD range shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices.
It is delivered cleaned but not sterile.
PERINE range
The guides from the PERINE range have an attachment system in which a perforated part is attached in order to place a needle. For some applications, there is a system with removable parts (nails) to adapt to the different diameters of needles. There is a possibility to have a fix or a movable system depending on the guide chosen.
The guides from the PERINE range shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices.
It is delivered cleaned but not sterile.
Steady Pro range
The Steady Pro range is a system which holds a 2D/3D lateral-fire endocavitary or 2D/3D endfire endocavitary ultrasound probe. It is an accessory of KOELIS systems.
The main functions of the Steady Pro range are:
- -To move the probe freely inside the working space of the probe holder in unlocked state
- -To maintain the probe in a specific position for an extended time when locked
- -To provide 6 degrees of freedom (rotation + translation) for arm and probe positioning; more specifically, to provide 160 degrees of rotation around the principal axis of the probe for side-fire probes, and 340 degrees of rotation for end-fire probes,
- -Easy to use: setup and operation, probe installation/dismantling, locking/unlocking the position,
- -Sterilizable and cleanable, easy to cover and protect.
| TITLE | 510(k) Summary | ID K171040 | Page 3 of 9 |
|---|---|---|---|
| ------- | ---------------- | ------------ | ------------- |
{6}------------------------------------------------
| Image: KOELIS logo | TRADITIONAL 510(K) |
|---|---|
| 510(k) Number: K171040 Version: 1.0 | |
| Pr-Name: - Date: 2017.07.10 |
Technological Characteristics compared with the cleared device:
CON-LEAD range and LIN-LEAD range
| Company | KOELIS | CIVCO |
|---|---|---|
| Devices | CON LEAD (abdominal guide) rangeImage: CON LEAD (abdominal guide) range | Ultrasound General PurposeGuidance:System(Ultra Pro II™)Image: Ultrasound General Purpose Guidance:System (Ultra Pro II™) |
| LIN LEAD (linear guide) rangeImage: LIN LEAD (linear guide) range | ||
| 510(k) number | Unknown | K093713 |
| Intended Use | The guides from CON-LEAD rangeand LIN-LEAD range are intended toguide a needle during ultrasound-guided interventions. | Intended for directing instrumentssuch as catheters, electrodes andneedles into a targeted anatomicallocation of a patient relative to theimaging instrument forpercutaneous procedures.Intended for percutaneousultrasound procedures |
| Design | Bracket adapted to the shape of theultrasound transducer. Space toslide a nail in. | Bracket adapted to the shape of theultrasound transducer. Space toslide a needle gauge insert in. |
| Nail with an unchanging externaldiameter and with an internaldiameter adapted to the needles. | Needle gauge insert withunchanging external dimensions andwith an internal channel adapted tothe instrument. |
| TITLE | 510(k) Summary | ID | K171040 | Page 4 of 9 |
|---|---|---|---|---|
| ------- | ---------------- | ---- | --------- | ------------- |
{7}------------------------------------------------
| Image: KOELIS logo | TRADITIONAL 510(k) | ||
|---|---|---|---|
| 510(k) Number: | K171040 | Version: | 1.0 |
| Pr-Name: | - | Date: | 2017.07.10 |
| Company | KOELIS | CIVCO |
|---|---|---|
| Material | Propylux (polymer) | Materials not specified in IFU orwebsite.Assumed to be a polymer. |
| Effectiveness | The design ensures accurate needlepath and placement in relation withthe transducer.Verification and validation wereperformed to ensure that devicesmeet requirements. | Verification was performed toensure that device meets specifiedtolerances and works in conjunctionwith specifically designed adapterclip area. |
| TITLE | 510(k) Summary | ID | K171040 | Page 5 of 9 |
|---|---|---|---|---|
| ------- | ---------------- | ---- | --------- | ------------- |
{8}------------------------------------------------
| Image: KOELIS logo | TRADITIONAL 510(K) | |
|---|---|---|
| 510(k) Number: | K171040 Version: 1.0 | |
| Pr-Name: - | Date: 2017.07.10 |
PERINE guides
| Company | KOELIS | CIVCO | |
|---|---|---|---|
| Device | Perine Nail | Perine Grid | Disposable Template Grid |
| 510(k)number | Unknown | K131161 | |
| IntendedUse | The guides from the PERINE range areintended to guide a needle duringultrasound-guided interventions. | Accepting and guiding needles upto 1.3 mm (18 gauge) in diameterand providing coordinates as anaid to needle loading andpositioning during radioactiveseed implantation, cryotherapy,transperineal template-guidedbiopsy, and/or fiducial markerplacement.Intended for ultrasoundpercutaneous (includingtransperineal) procedures | |
| Design | Clipping system to clip the guide on theprobe.Perine Nail : vertical grid with openedchannels to slide a nail in.Nail with an unchanging externaldiameter and with an internaldiameter adapted to the needles. | Perine Grid : vertical grid with closedchannels to directly slide a needle in. | Notch to fit on the stepping unit.Square grid with closed channelsto directly slide aneedle/instrument in.- |
| TITLE | 510(k) Summary | ID | K171040 | Page 6 of 9 |
|---|---|---|---|---|
| ------- | ---------------- | ---- | --------- | ------------- |
{9}------------------------------------------------
| Image: KOELIS logo | TRADITIONAL 510(K) | |
|---|---|---|
| 510(k) Number: K171040 | Version: 1.0 | |
| Pr-Name: - | Date: 2017.07.10 |
| Company | KOELIS | CIVCO |
|---|---|---|
| Material | Propylux (polymer) | ABS (polymer) |
| Effectiveness | The design ensures accurate needle pathand placement in relation with thetransducer.Verification and validation wereperformed to ensure that devices meetrequirements. | Validation was conducted toconfirm the device remains safeand effective for its intended use. |
| TITLE | 510(k) Summary | ID | K171040 | Page 7 of 9 |
|---|---|---|---|---|
| ------- | ---------------- | ---- | --------- | ------------- |
{10}------------------------------------------------
| Image: KOELIS logo | TRADITIONAL 510(K) |
|---|---|
| 510(k) Number: K171040 Version: 1.0 | |
| Pr-Name: - Date: 2017.07.10 |
Steady Pro range
| Company | KOELIS | CIVCO |
|---|---|---|
| Device | Steady Pro range | Accucare™ micro-touch LP |
| 510(k) number | Unknown | K131161 |
| Intended Use | Intended to reliably maintain theposition of a transrectal ultrasoundprobe during ultrasound-guidedinterventions. Typical applicationsare biopsy or cancer treatment. | Holding and manipulatingultrasound imaging probes duringprostate brachytherapy,cryotherapy, transperinealtemplate-guided biopsy, and/orfiducial marker placementprocedures (including volumedetermination of the prostategland), and/or the application ofradionuclide source(s) into the bodyduring brachytherapy. |
| Design | Metallic holding arm with probesupports in polymer. | Metallic arm mounted on a tablewith a stabilizer |
| Material | Propylux (polymer) and stainlesssteel | Material is not specified in IFU orwebsite.Assumed to be a metallic material. |
| Effectiveness | The design ensures accurate holdingof the transducer.Verification and validation wereperformed to ensure that devicesmeet requirements. | Non-clinical performance testingwas conducted including verificationtesting: Stepping Unit is able toprovide continuous (free)longitudinal movement.Validation was also conducted toconfirm the device remains safe andeffective for its intended use. |
| Carol & Company | E 1 0 / 1 / 1 / 0 / 1 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0JImmlaru | UNTAL C(14) | Page 'or | |
|---|---|---|---|---|
| ----------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | ----------------- | -------------- |
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| TRADITIONAL 510(K) | ||
|---|---|---|
| 510(k) Number: | K171040 Version: 1.0 | |
| Pr-Name: | - Date: 2017.07.10 |
Summary of Non-Clinical Tests
The devices from the reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range have been evaluated for biocompatibility, cleaning and disinfection effectiveness and have been found to be compliant with applicable medical device safety standards. The devices and their applications comply with voluntary standards.
Summary of Clinical Tests
The subject of this premarket submission did not require clinical studies to support substantial equivalence.
Conclusion:
KOELIS considers the subject devices to be as safe, as effective and with performance substantially equivalent to the predicate devices.
| TITLE | 510(k) Summary | ID | K171040 | Page 9 of 9 |
|---|---|---|---|---|
| ------- | ---------------- | ---- | --------- | ------------- |
§ 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.