(63 days)
Not Found
No
The device description and performance studies focus on mechanical features and physical properties, with no mention of AI or ML algorithms, data processing, or learning capabilities.
No
The device is described as an "accessory" used to lock guidewires and prevent reflux, which are supportive functions for endoscopic procedures, not direct therapeutic actions on the patient.
No
The device is described as an accessory used with endoscopic devices to lock wire guides and prevent reflux of body fluids. Its functions are mechanical (locking, sealing) and do not involve detecting, monitoring, or analyzing physiological data or conditions to make a diagnosis.
No
The device description clearly details physical components (skirt, lock arm, biopsy cap, seals) and their mechanical functions (attaching, locking, preventing reflux). There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to lock guidewires in place during endoscopic procedures and prevent reflux of body fluids. This is a mechanical function performed in vivo (within the body) during a medical procedure.
- Device Description: The description details a mechanical accessory that attaches to an endoscope. It describes physical components and their functions related to manipulating guidewires and sealing the biopsy port.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens, samples, or data derived from the human body in vitro (outside the body) to provide information for diagnostic purposes.
- Performance Studies: The performance studies focus on mechanical and physical properties (engagement, locking force, leak testing, etc.), not on the accuracy or reliability of diagnostic results.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to diagnose diseases or conditions. This device is a procedural accessory used during an endoscopic procedure.
N/A
Intended Use / Indications for Use
The locking device is an accessory used with endoscopic devices to lock the wire guide(s) in place during endoscopic procedures (e.g. ERCP). The integrated biopsy cap is designed to prevent reflux of body fluids.
Product codes
ODC
Device Description
The CleverLock Guidewire Locking Device and Biopsy Cap is an accessory used with compatible endoscopic devices to lock the wire guide(s) in place during endoscopic procedures. The two components of the device are the guidewire locking device and the biopsy cap.
The skirt portion of the locking device is designed to attach to the biopsy port located on the endoscope barrel. The rigid skirt is matched to fit the scope handle to prevent its rotating during a wire engagement or disengagement. The lock arm has three (3) locking mechanisms (wire slots): inner slot, outer slot and lower slot to accommodate up to three (3) guidewires. The locking feature has a geometry which results in an "audible" click with tactile feedback when the wire has been fully engaged.
The biopsy cap is comprised of a cap seal and inner seal. The cap seal sits on top of the locking device skirt. The cap seal is designed with a self-closing slit to minimize fluid passage when all devices are removed from the biopsy channel. The inner seal attaches to the snap fit portion of the locking device; and is designed with a round opening to minimize fluid passage when there is a device inserted into the biopsy channel.
The CleverLock Locking Device and Biopsy Cap is available in one model only (MAJ-2455). The proposed CleverLock Locking Device and Biopsy Cap will be sold sterile and is intended for single patient use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility:
Biocompatibility testing on all patient contacting surfaces has been performed in compliance to relevant requirements of ISO-10993. Biocompatibility testing included the following tests:
- ISO 10993-5: 2009 Biological evaluation of medical devices Part5: Tests for . in vitro cytotoxicity
- ISO 10993-10: 2010 Biological evaluation of medical devices. Tests for . irritation and sensitization
- ISO 10993-11: 2017 Biological evaluation of medical devices Part 11: Tests . for systemic toxicity
- United States Pharmacopeia 41, National Formulary 36, 2018. Pyrogen ● Test
Sterilization:
The CleverLock will be delivered in a sterile state and is intended for single patient use only. Sterilization (gamma radiation) and packaging of the device was validated using the following standards:
- ANSI/AAMI/ISO 11607-1:2006 Packaging for terminally sterilized medical ● devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ANSI/AAMI/ISO 11137-2:2013 Sterilization of health-care products -Radiation - Part 2: Establishing the sterilization dose
Packaging integrity and performance testing on devices that had undergone accelerated aging support a labeled three-year shelf life.
Bench testing:
During design verification, the output of the design process was evaluated against the physical and performance specifications. The following performance tests were conducted:
- Scope Engagement Test
- Wire Locking Force Test
- Wire Retention and Lock Removal
- Insertion Force Test
- Leak Test
- Brush, Unlocking Test
- Angle Test
- Decay Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 4, 2019
Olympus Surgical Technologies America Mary Anne Patella Senior Specialist, Regulatory Affairs 136 Turnpike Road Southborough, MA 01772-2104
Re: K190164
Trade/Device Name: CleverLock Guidewire Locking Device and Biopsy Cap Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODC Dated: January 30, 2019 Received: January 31, 2019
Dear Mary Anne Patella:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Mark J. Antonino -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
CleverLock Guidewire Locking Device and Biopsy Cap
Indications for Use (Describe)
The locking device is an accessory used with endoscopic devices to lock the wire guide(s) in place during endoscopic procedures (e.g. ERCP). The integrated biopsy cap is designed to prevent reflux of body fluids.
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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3
K190164 Page 1 of 4
510(k) Summary CleverLock Guidewire Locking Device and Biopsy Cap
General Information
| Contract Manufacturer: | PMC, LLC
1451 S. Miller Avenue
Shelbyville, IN 46176
Phone: 317-421-2515 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3010408671 |
| 510(k) Submitter: | Olympus Surgical Technologies
America
Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough, MA 01772-2104
Phone: 508-804-2600
Fax: 508-804-2624 |
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Mary Anne Patella
Senior Specialist, Regulatory Affairs
508-804-2771
Maryanne.patella@olympus-osta.com |
| Date Prepared: | January 29, 2019 |
Device Description
| Classification Name: | Endoscope and accessories |
|---|---|
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | ODC |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
| Trade Name: | CleverLock Guidewire Locking Device |
| and Biopsy Cap | |
| Generic/Common Name: | Locking device |
Predicate DeviceWilson-Cook USW Cap and Wire Lock
4
Product Description
The CleverLock Guidewire Locking Device and Biopsy Cap is an accessory used with compatible endoscopic devices to lock the wire guide(s) in place during endoscopic procedures. The two components of the device are the guidewire locking device and the biopsy cap.
The skirt portion of the locking device is designed to attach to the biopsy port located on the endoscope barrel. The rigid skirt is matched to fit the scope handle to prevent its rotating during a wire engagement or disengagement. The lock arm has three (3) locking mechanisms (wire slots): inner slot, outer slot and lower slot to accommodate up to three (3) guidewires. The locking feature has a geometry which results in an "audible" click with tactile feedback when the wire has been fully engaged.
The biopsy cap is comprised of a cap seal and inner seal. The cap seal sits on top of the locking device skirt. The cap seal is designed with a self-closing slit to minimize fluid passage when all devices are removed from the biopsy channel. The inner seal attaches to the snap fit portion of the locking device; and is designed with a round opening to minimize fluid passage when there is a device inserted into the biopsy channel.
The CleverLock Locking Device and Biopsy Cap is available in one model only (MAJ-2455). The proposed CleverLock Locking Device and Biopsy Cap will be sold sterile and is intended for single patient use only.
Intended Use
The locking device is an accessory used with endoscopic devices to lock the wire guide(s) in place during endoscopic procedures (e.g. ERCP). The integrated biopsy cap is designed to prevent reflux of body fluids.
Technological Characteristics
The CleverLock has the same basic technological characteristics as the predicate Fusion Wire Guide Locking Device cleared under K040137. The subject and predicate device operate in the same manner to lock the wire guide(s) in place during endoscopic procedures. The indications for use of the CleverLock are the same as that of the predicate.
A detailed comparison of the CleverLock and its' predicate is provided in the following table.
5
Traditional 510(k) Notification
January 29, 2019
| Table 5.1 Comparison of Proposed and Predicate Device | |||
|---|---|---|---|
| Device Name/ Characteristics | Proposed Device | Predicate Device (K040137) | Comments |
| Indications for Use | CleverLock Guidewire and Biopsy Cap | ||
| The locking device is an accessory used with endoscopic devices to lock the wire guide(s) in place during endoscopic procedures (e.g. ERCP). The integrated biopsy cap is designed to prevent reflux of body fluids. | Fusion Wire Guide Locking Device | ||
| The Wilson-Cook USW Cap and Wire Lock Device is an accessory to be used with endoscopic biliary devices to lock the wire guide(s) in place during ERCP procedures. | Same as predicate | ||
| Device Function | Guidewire Locking Device with Biopsy Cap | Guidewire Locking Device with Cap | Same as predicate |
| Mechanics of Action | Manual | Manual | Same as predicate |
| Indirect Patient Contacting Materials | Main body: Polycarbonate Makrolon Rx2530 | Plastic, unknown formulation | Similar to predicate; any differences confirmed through testing. |
| Seal, Inside Rubber: Silicone KE-944-U | Rubber, unknown formulation | ||
| Seal Cover: Silicone KEG-2001-50-A/B | |||
| Biocompatible | Yes | Unknown | Biocompatibility Tests passed |
| Sterilization | Gamma Radiation | Ethylene Oxide | Sterilization Validation passed |
| Single Use Only | Yes | Yes | Same as predicate |
| Attaches directly to the accessory port | Yes | Yes | Same as predicate |
| Double valve biopsy cap | Yes | Yes | Same as predicate |
| Wire Guide Diameter | .035" | .035" | Same as predicate |
| Secure guidewires of various sizes | .025" to .035" ET Guidewires | ||
| .018" to .025" ERCP Guidewires | .025" or .018" guidewires | Same as predicate | |
| Multiple locking positions | 3 | 2 | Similar to predicate |
| Table 5.1 Comparison of Proposed and Predicate Device | ||
|---|---|---|
Summary of Non-Clinical Testing
Biocompatibility:
Biocompatibility testing on all patient contacting surfaces has been performed in compliance to relevant requirements of ISO-10993. Biocompatibility testing included the following tests:
- ISO 10993-5: 2009 Biological evaluation of medical devices Part5: Tests for . in vitro cytotoxicity
6
- ISO 10993-10: 2010 Biological evaluation of medical devices. Tests for . irritation and sensitization
- ISO 10993-11: 2017 Biological evaluation of medical devices Part 11: Tests . for systemic toxicity
- United States Pharmacopeia 41, National Formulary 36, 2018. Pyrogen ● Test
Sterilization:
The CleverLock will be delivered in a sterile state and is intended for single patient use only. Sterilization (gamma radiation) and packaging of the device was validated using the following standards:
- ANSI/AAMI/ISO 11607-1:2006 Packaging for terminally sterilized medical ● devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ANSI/AAMI/ISO 11137-2:2013 Sterilization of health-care products -Radiation - Part 2: Establishing the sterilization dose
Packaging integrity and performance testing on devices that had undergone accelerated aging support a labeled three-year shelf life.
Bench testing:
During design verification, the output of the design process was evaluated against the physical and performance specifications. The following performance tests were conducted:
- Scope Engagement Test
- Wire Locking Force Test ●
- Wire Retention and Lock Removal ●
- Insertion Force Test
- Leak Test ●
- Brush, Unlocking Test ●
- Angle Test
- Decay Test ●
Conclusion:
In summary, the CleverLock Guidewire Locking Device and Biopsy Cap is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness.