(189 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML.
No
The device, a guidewire, is used for selective cannulation and catheter introduction/exchanges during endoscopic biliary procedures. It facilitates a medical procedure but does not directly provide therapy or treatment itself.
No
Explanation: The device is a guidewire used for selective cannulation of biliary ducts during endoscopic procedures, facilitating catheter introduction and exchanges. Its function is to provide guidance for other instruments, not to diagnose medical conditions or analyze patient data.
No
The device description clearly outlines physical components (Nitinol core wire, PTFE jacket, copolymer distal section, stainless steel spring section) and mentions bench/performance testing related to these physical attributes (Fracture Test, Bend Test, Friction Test, Scratch Test, Tensile Test, Radiographic Image Test). This indicates it is a physical medical device, not software-only.
Based on the provided information, the EasyPass Guidewire is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- EasyPass Guidewire Function: The description clearly states the EasyPass Guidewire is used for selective cannulation of the biliary ducts during endoscopic biliary procedures. This is a procedure performed within the body to access and manipulate anatomical structures.
- No Sample Testing: There is no mention of the device being used to test samples or provide diagnostic information based on analysis of biological material.
The EasyPass Guidewire is an invasive surgical/interventional device used to facilitate procedures within the body, not a device for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The EasyPass Guidewire is used for selective cannulation of the biliary ducts including, but not limited to the common bile duct, cystic duct, and right and left hepatic ducts. The EasyPass guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.
Product codes
OCY
Device Description
The EasyPass Guidewire consists of a Nitinol core wire with a proximal 2-color spiral patterned PTFE jacket and a copolymer distal section. The distal stainless steel spring section of the guidewire provides flexibility and incorporates a hydrophilic coating. The EasyPass Guidewire is a sterile packed, disposable instrument 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
biliary ducts including, but not limited to the common bile duct, cystic duct, and right and left hepatic ducts.
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
The following non-clinical performance tests were conducted on the proposed EasyPass Guidewire:
- Biocompatibility testing per ISO 10993: Cytotoxicity, Irritation, Sensitization
- USP Class VI Testing performed on color additives
- Bench/performance testing consisted of: Fracture Test, Bend Test, Friction Test, Scratch Test, Tensile Test, Radiographic Image Test
Key Metrics
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 18, 2016
Medi-Globe Corporation Scott Karler Regulatory Affairs Coordinator 7850 South Hardy Drive, Suite. 112 Tempe, AZ 85284
Re: K153264
Trade/Device Name: EasyPass Guidewire Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCY Dated: April 7, 2016 Received: April 13, 2016
Dear Scott Karler:
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.
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 (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 vours.
Herbert P. Lerner -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
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) | K153264 |
|---|---|
| Device Name | EasyPass Guidewire |
| Indications for Use (Describe) | The EasyPass Guidewire is used for selective cannulation of the biliary ducts including, but not limited to the common bile duct, cystic duct, and right and left hepatic ducts. The EasyPass guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges. |
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.
(AN/8) 1886 AQ3 MAO3
ခုေပြေ
ປີ ປະຈຸບັນ ( ໄປນີ້ ) ແລວ ເຄລາ ຄວາ ສາມາດ ສາມາດສານປະການ ລົງສຸ
3
ົວຂອງ ໄດ້ ເວີຍ ແລ່ງວັນນ້ອຍການປະກວດນາງງາມ ປີ ປຸກາ ຂອງໄປປຸ່ນ ແລະວ່າໄປປຸ່ນ ແວ່ງວ່າ ຂໍ້ມັ
iseqs redio your and exemites nebud sint pribremori in noilemorii in noileemore ent əri bulbuları ,əsrlədən vəd suvorların əsasən və bateminə sinə aid ini və əmir nəbud əri ətələr və bərən əsasən əsasən və qalını qarşının ətəb çərir. Bu və bir və illər və qalında və bir mill of the same and the mails are and of the common and and
:of ,nebrud sint prisuber 101 suoitzaggus pribuloni ,unitsellos noilsmonni siril 10 vog.zdy.spy@jtfillelsAAP 1912 (AR9) ISA noilloubes വാഗ്യാപക Office of Chief Information Officer noilerisinimbA pung bung boo รอว่างาอร์ ทรการ Home HillseH To เมือกการตุลอ
้า ติดใจอีกดว ธ , ot bnoqser of beiluper ใดต ร่านตราคาร เวทราคาราชอาณา เอก เยก บุคคล พ.ศ. 2019 บุคคลจากคำ
4
510(k) SUMMARY
Date of Preparation: 11/09/2015
A. Submitter Information:
Medi-Globe Corporation 7850 S. Hardy Drive, #112 Tempe, Arizona 85284
Contact Person: Scott Karler Telephone: (480) 897-2772 ext. 208 Fax: (480) 897-2878 Email: skarler@mediglobe.com
B. Proposed Device Information:
- Trade Name: EasyPass Guidewire
- 2 Common Name: Endoscopic Guidewire, Gastroenterology-Urology
- ಷ Classification Name: Endoscope and Accessories 21 CFR876.1500
- Σ Product Code: ΟCY
C. Predicate Device:
- Trade Name: Taxi Endoscopic Guidewire
- ಷ Manufacturer: Lake Region Manufacturing, Inc.
- と Clearance Number: K081708
- Σ Common Name: Endoscopic Guidewire, Gastroenterology-Urology
- Classification Name: Endoscope and Accessories 21 CFR876.1500
- Product Code: OCY
D. Device Description:
The EasyPass Guidewire consists of a Nitinol core wire with a proximal 2-color spiral patterned PTFE jacket and a copolymer distal section. The distal stainless steel spring section of the guidewire provides flexibility and incorporates a hydrophilic coating. The EasyPass Guidewire is a sterile packed, disposable instrument intended for single-patient use only.
E. Indications for Use:
The EasyPass Guidewire is used for selective cannulation of the biliary ducts including, but not limited to the common bile duct, cystic duct, and right and left hepatic ducts. The EasyPass guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.
5
F. Technological Characteristics Summary:
The EasyPass Guidewire is a 2-color spiral patterned guidewire used in endoscopic procedures. It is comprised of a Nitinol core wire with a 2-color PTFE jacket as a visualization aid during use of the guidewire. The distal section of the EasyPass Guidewire consists of a stainless steel spring encased in a polymer jacket and is hydrophilically coated. The predicate device, Taxi Endoscopic Guidewire. (K081708) incorporates the same design. intended use. diagnostic/therapeutic effect, method of introduction/use, technical characteristics and general range of descriptive features as the proposed. EasyPass Guidewire. There are no technological differences when comparing the proposed EasyPass Guidewire to the predicate device.
G. Non-Clinical Performance Data:
Design verification data and biocompatibility testing has demonstrated that the proposed EasyPass Guidewire meets the same performance requirements and is as safe and effective as predicate device, Taxi Endoscopic Guidewire, (K081708).
The following non-clinical performance tests were conducted on the proposed EasyPass Guidewire:
Biocompatibility testing per ISO 10993: Cytotoxicity Irritation Sensitization
USP Class VI Testing performed on color additives
- Bench/performance testing consisted of: Fracture Test Bend Test Friction Test Scratch Test Tensile Test Radiographic Image Test
Conclusions of Non-Clinical Performance Data: H.
Medi-Globe Corporation has demonstrated that the proposed EasyPass Guidewire is as safe and effective as the predicate device, (Taxi Endoscopic Guidewire, K081708). The EasyPass Guidewire is considered to have the same intended use, diagnostic/therapeutic effect. method of introduction/use. technical characteristics and general range of descriptive features as the predicate device. (Taxi Endoscopic Guidewire. K081708). No clinical testing was relied on for evaluation of the proposed device.