(210 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML, image processing, or data analysis.
No
This device is designed to guide other instruments, collect tissue, specimens, or cells, and scrape tissue for diagnostic examination. It does not provide therapy or treatment.
Yes
The device (specifically the biopsy forceps, cytology brush, and guiding device) is explicitly designed to "collect tissue, specimens, or cells bronchoscopically" and "for examination" or "for cytologic examination." The collection of biological samples for examination is a fundamental part of diagnosis. The guide sheath facilitates the use of these collection tools to reach the target area for sampling.
No
The device description clearly outlines physical components such as guide sheaths, biopsy forceps, cytology brushes, and stoppers, which are hardware. The performance studies also focus on physical characteristics like sterilization, shelf-life, biocompatibility, tensile strength, and trackability.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is used to guide other instruments (EndoTherapy accessories, ultrasonic probes) to a target area within the body (tracheobronchial tree, respiratory organs) and to collect tissue, specimens, or cells.
- Mechanism of Action: The device facilitates the collection of samples from within the body using mechanical means (biopsy forceps, cytology brush, curette).
- No In Vitro Analysis: The description does not mention any component or function that performs analysis or examination of the collected samples outside of the body. The samples are collected for subsequent examination (cytologic examination, examination with a flexible bronchoscope), but the device itself is not involved in that examination process.
IVD devices are specifically designed to examine specimens in vitro (outside of the body) to provide information for diagnosis, monitoring, or screening. This device is a tool for collecting those specimens from within the body.
N/A
Intended Use / Indications for Use
Single Use Guide Sheath Kit K-401, K-402 These instruments have been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically. This kit and its components are intended for adult patients only.
- Indications for use of each component
Single Use Guide Sheath SG-400C The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and for ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.
Single Use Biopsy Forceps FB-433D The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible bronchoscope within the tracheobronchial tree.
Single Use Cytology Brush BC-205D The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with the bronchoscope within the tracheobronchial tree.
Single Use Guiding Device CC-220DR This instrument has been designed to be used with an Olympus endoscope and guide sheath to the respiratory organs and to collect specimens within the respiratory organs. This device is intended for adult patients only.
Product codes (comma separated list FDA assigned to the subject device)
EOQ, BTG
Device Description
Single Use Guide Sheath Kit K-401/K-402
The kit has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically.
The compatible bronchoscope for the subject Single Use Guide Sheath Kit needs to have the working length 600mm or less (exclude the ultrasonic bronchoscope) and a working channel inner diameter that is no less than 2.0mm.
The guide sheath kit consists of the following components: Guide Sheath, Biopsy Forceps, with/without Cytology Brush. EU stoppers and US Stopper are also included in the kit as accessories. Each component and the accessory stoppers are sterile and packaged in individual package. All of them are collected into one carton box as one final kit product.
The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.
This guide sheath is designed to function as an extended working channel. The function of the subject guide sheath is to facilitate obtaining multiple biopsy specimens by leaving the guide sheath in place after localization of the target tissue.
This instrument consists of an insertion portion and a handle portion. The insertion portion is composed of tube and X-ray tip.
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope. The subject device is allowed to insert into the channel of a bronchoscope with the subject device guide sheath, and then collect tissue with the pair of forceps which is equipped at the distal end of the subject device. Finally, users withdraw the subject device biopsy forceps from the bronchoscope to collect the samples.
The single use cytology brush BC-205D has been designed to collect specimens or cells endoscopically for cytology examination in conjunction with bronchoscopes. The subject device is allowed to insert into the channel of a bronchoscope with the subject device guide sheath, and then collect specimens or cells with the brush which is affixed in the distal end of the subject device. Finally, users withdraw the subject device cytology brush from the bronchoscope to collect the samples.
The ET stopper and US stopper are included in the guide sheath kit as accessory. They are used to fasten the sampling devices (EndoTherapy accessories) or ultrasonic probe to the guide sheath, which serve as a mark to keep the sampling devices or ultrasonic probe in relative position to the guide sheath. The ET stopper are made of silicone rubber outside, molded with stainless steel plate inside.
Single Use Guiding Device CC-220DR
The Single Use Guiding Device has been designed to be used with an Olympus endoscope and guide sheath to guide the guide sheath to the respiratory organs and to collect specimens within the respiratory organs.
The compatible bronchoscope for the subject Single Use Guiding Device CC-220DR needs to have the working length 600mm or less (exclude the ultrasonic bronchoscope) and a working channel inner diameter that is no less than 2.0mm.
The subject device consists of a handle section and an insertion. The distal end in the insertion portion consists of a double-joint curette which bends by operating the handle section. The rotation grip in handle section also allows for rotation of the curette in the distal end. The subject device inserts into an endoscope with the guide sheath, and enables the guide sheath to be directed to the target area following the direction the curette in distal end to the target area. The curette can also collect the specimen by scraping the tissue.
Although this device is used together with the subject device guide sheath in Single Use Guide Sheath Kit, it is marketed independently as a single product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheobronchial tree, respiratory organs
Indicated Patient Age Range
adult patients only
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)
Sterilization/shelf-life testing for the Single Use Guide Sheath Kit and the Single Use Guiding Device were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Prior to the shelf-life testing, simulated distribution tests as well as accelerated aging test were carried out on the test samples of subject device in final finished form.
The real-time aging test for one-year (Single Use Guide Sheath Kit) and three-years (Single Use Guiding Device CC-220DR) to demonstrate the claimed stability and support the results of the accelerated aging test for the subject devices.
Biocompatibility testing for Single Use Guide Sheath Kit and the Single Use Guiding Device were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
Performance testing was carried out to demonstrate the safety and the effectiveness of the subject devices.
- Radiographic Testing
- Catheter Joint/Tensile Testing
- Dimensional Testing
- Simulated Use Testing
- Trackability Testing (insertion & withdrawal)
Risk analysis for the Single Use Guide Sheath Kit and the Single Use Guiding Device was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K060243, K172726, K190293, K060243
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 6, 2020
Olympus Medical Systems Corp. % Jonathan Gilbert Regulatory Affairs Consultant to OCA Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K192164
Trade/Device Name: Single Use Guide Sheath Kit K-401, K-402, Single Use Guiding Device CC-220DR Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ, BTG Dated: January 31, 2020 Received: February 3, 2020
Dear Jonathan Gilbert:
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. Although this letter refers to your product as a device, please be aware 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. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for James J. Lee Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192164
Device Name
Single Use Guide Sheath Kit K-401, K-402 & Single Use Guiding Device CC-220DR
Indications for Use (Describe) Single Use Guide Sheath Kit K-401, K-402
These instruments have been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically. This kit and its components are intended for adult patients only.
- Indications for use of each component
Single Use Guide Sheath SG-400C
The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and for ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.
Single Use Biopsy Forceps FB-433D
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible bronchoscope within the tracheobronchial tree.
Single Use Cytology Brush BC-205D
The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with the bronchoscope within the tracheobronchial tree.
Single Use Guiding Device CC-220DR
This instrument has been designed to be used with an Olympus endoscope and guide sheath to the respiratory organs and to collect specimens within the respiratory organs. This device is intended for adult patients only.
Type of Use (Select one or both, as applicable)
X 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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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. There is a yellow line underneath the word. The registered trademark symbol is located to the right of the letter "S".
Single Use Guide Sheath Kit & Single Use Guiding Device CC-220DR
March 5, 2020
1. General Information
| ■ 510(k) submitter: | OLYMPUS MEDICAL SYSTEMS CORP. |
|---|---|
| 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, | |
| Japan | |
| Establishment Registration No: 8010047 | |
| ■ Contact Person: | Jon Gilbert fbo Sheri Musgnung. |
| Olympus Corporation of the Americas | |
| 3500 Corporate Parkway PO Box 610 | |
| Center Valley, PA 18034-0610, USA | |
| Phone: 484-896-3147 | |
| FAX: 484-896-7128 | |
| Email: sheri.musgnung@olympus.com | |
| ■ Manufacturing site: | Aomori Olympus Co., Ltd. |
| 2-248-1 Okkonoki, Kuroishi-shi, Aomori, 036-0357, | |
| Japan | |
| Establishment Registration No.: 9614691 |
2. Device Identification
| ■ Device Trade Name: | Single Use Guide Sheath Kit K-401, K-402 |
|---|---|
| [Component] | |
| - Single Use Guide Sheath SG-400C | |
| - Single Use Biopsy Forceps FB-433D | |
| 510(k) Summary | |
| Page 1 of 11 |
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| - Single Use Cytology Brush BC-205D | |
|---|---|
| ET Stopper / US Stopper | |
| & Single Use Guiding Device CC-220DR | |
| ■ Common Name: | Guide Sheath Kit & Guiding Device |
| ■ Regulation Number: | 874.4680 |
| ■ Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| ■ Regulatory Class: | II |
| ■ Classification Panel: | Ear Nose & Throat |
| ■ Product Code: | EOO , BTG |
3. Predicate Device Information
Predicate device for Single Use Guide Sheath SG-400C
| ■ Device Name: | Olympus Guide Sheath, XBO1-836-13 |
|---|---|
| ■ Common Name: | Bronchoscope accessory |
| ■ Applicant | Olympus Medical System Corporation |
| ■ 510(k) No. | K060243 |
Predicate device for Single Use Biopsy Forceps FB-433D
- Device Name: Single Use Biopsy Forceps FB-433D
510(k) Summary Page 2 of 11
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| ■ Common Name: | Biopsy forceps |
|---|---|
| ■ Applicant | Olympus Medical Systems Corp. |
| ■ 510(k) No. | K172726 |
| Predicate device for Single Use Cytology Brush BC-205D | |
| ■ Device Name: | Single Use Cytology Brush BC-205D |
| ■ Common Name: | Cytology brush |
| ■ Applicant | Olympus Medical Systems Corp. |
| ■ 510(k) No. | K190293 |
| Predicate device for Single Use Guiding Device CC-220DR | |
| ■ Device Name: | CC-4CR-1 Curette (Double-hinged type) |
| ■ Common Name: | Curette |
| ■ Applicant | Olympus Medical Systems Corp. |
Device Description 4.
■ 510(k) No.
Single Use Guide Sheath Kit K-401/K-402
The kit has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically.
510(k) Summary Page 3 of 11
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The compatible bronchoscope for the subject Single Use Guide Sheath Kit needs to have the working length 600mm or less (exclude the ultrasonic bronchoscope) and a working channel inner diameter that is no less than 2.0mm.
The guide sheath kit consists of the following components: Guide Sheath, Biopsy Forceps, with/without Cytology Brush. EU stoppers and US Stopper are also included in the kit as accessories. Each component and the accessory stoppers are sterile and packaged in individual package. All of them are collected into one carton box as one final kit product. Please refer to Table 1 below.
| Components/Accessories in each kit* | ||
|---|---|---|
| Kit Model | K-401 | K-402 |
| Guide Sheath | SG-400C | |
| Biopsy Forceps | FB-433D | |
| Cytology Brush | BC-205D-2010 | NA |
| ET Stopper | ||
| Color: White | Quantity: 4 | Quantity: 3 |
| US Stopper | ||
| Color: Dark gray | Quantity: 1 | Quantity: 1 |
Table 1 Configuration of Each Kit Model and te/Acc ries in ea h 1-i+* C
*Note: The Guiding Device CC-220DR is not part of either kit model but is to be used with the subject guide sheath, and will be sold separately from the kits.
The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.
This guide sheath is designed to function as an extended working channel. The function of the subject guide sheath is to facilitate obtaining multiple biopsy specimens by leaving the guide sheath in place after localization of the target tissue.
510(k) Summary Page 4 of 11
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Image /page/8/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is centered in the image. The font is sans-serif, and the letters are all uppercase. There is a registered trademark symbol to the right of the letter "S".
This instrument consists of an insertion portion and a handle portion. The insertion portion is composed of tube and X-ray tip.
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope. The subject device is allowed to insert into the channel of a bronchoscope with the subject device guide sheath, and then collect tissue with the pair of forceps which is equipped at the distal end of the subject device. Finally, users withdraw the subject device biopsy forceps from the bronchoscope to collect the samples.
The single use cytology brush BC-205D has been designed to collect specimens or cells endoscopically for cytology examination in conjunction with bronchoscopes. The subject device is allowed to insert into the channel of a bronchoscope with the subject device guide sheath, and then collect specimens or cells with the brush which is affixed in the distal end of the subject device. Finally, users withdraw the subject device cytology brush from the bronchoscope to collect the samples.
The ET stopper and US stopper are included in the guide sheath kit as accessory. They are used to fasten the sampling devices (EndoTherapy accessories) or ultrasonic probe to the guide sheath, which serve as a mark to keep the sampling devices or ultrasonic probe in relative position to the guide sheath. The ET stopper are made of silicone rubber outside, molded with stainless steel plate inside.
Single Use Guiding Device CC-220DR
The Single Use Guiding Device has been designed to be used with an Olympus
510(k) Summary Page 5 of 11
9
endoscope and guide sheath to guide the guide sheath to the respiratory organs and to collect specimens within the respiratory organs.
The compatible bronchoscope for the subject Single Use Guiding Device CC-220DR needs to have the working length 600mm or less (exclude the ultrasonic bronchoscope) and a working channel inner diameter that is no less than 2.0mm.
The subject device consists of a handle section and an insertion. The distal end in the insertion portion consists of a double-joint curette which bends by operating the handle section. The rotation grip in handle section also allows for rotation of the curette in the distal end. The subject device inserts into an endoscope with the guide sheath, and enables the guide sheath to be directed to the target area following the direction the curette in distal end to the target area. The curette can also collect the specimen by scraping the tissue.
Although this device is used together with the subject device guide sheath in Single Use Guide Sheath Kit, it is marketed independently as a single product.
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5. Indications for Use
Single Use Guide Sheath Kit K-401, K-402
These instruments have been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically. This kit and its components are intended for adult patients only.
Single Use Guide Sheath SG-400C
The single use guide sheath has been designed to be used with Olympus bronchoscopes. EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.
Single Use Biopsy Forceps FB-433D
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope within the tracheobronchial tree.
Single Use Cytology Brush BC-205D
The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with the bronchoscope within the tracheobronchial tree.
Single Use Guiding Device CC-220DR
This instrument has been designed to be used with an Olympus endoscope and guide sheath to guide the guide sheath to the respiratory organs and to collect specimens within the respiratory organs. This device is intended for adult patients only.
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Image /page/11/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. There is a registered trademark symbol to the right of the letter "S". The background is white.
6. Comparison of Technological Characteristics
In comparison to their corresponding predicate devices, components of the subject device Single Use Guide Sheath Kit K-401/K-402 and the Single Use Guiding Device CC-220DR have similar technological characteristics as their predicate devices except for the following differences.
Singe Use Guide Sheath Kit K-401/K-402
- Dimension of diameter and length -
- Patient contact materials -
- Compatible bronchoscope and accessory ।
- -Sterilization method
Similar as predicate device, except that this component is intended to be compatible to use with the Single Use Guide Sheath SG-400C and compatible bronchoscope together. As the component in the Singe Use Guide Sheath Kit K-401/K-402, the shelf-life of the Single Use Biopsy Forceps FB-403D is claimed to be one-year.
Similar as predicate device, except that this component is intended to be compatible to use with the Single Use Guide Sheath SG-400C and compatible bronchoscope together. As the component in the Singe Use Guide Sheath Kit K-401, the shelf-life of the Single Use Cytology Brush BC-205D is claimed to be one-year.
Single Use Guiding Device CC-220DR
- Sterilized status and package -
- -Compatible device
- -Device dimension
- Material of handle -
The differences above have been validated and it is demonstrated that these technological
510(k) Summary Page 8 of 11
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features do not raise no new safety issues and are substantially equivalent to the predicate device.
The following standards have been applied to the Single Use Guide Sheath Kit and the Single Use Guiding Device.
| Standard No. | Standard Title |
|---|---|
| ISO11135 Second Edition | |
| 2014 | Sterilization of Health-Care Products, Ethylene Oxide - |
| Requirements for the Development, Validation and | |
| Routine Control of a Sterilization Process for Medical | |
| Devices | |
| ISO 10993-7 Second | |
| edition 2008-10-15 | Biological evaluation of medical devices - part 7: ethylene |
| oxide sterilization residuals | |
| ISO 11607-1 First edition | |
| 2006-04-15 | Packaging for terminally sterilized medical devices - part |
| 1: requirements for materials, sterile barrier systems and | |
| packaging systems | |
| ISO 11607-2 First edition | |
| 2006-04-15 | Packaging for terminally sterilized medical devices - part |
| 2: validation requirements for forming, sealing and | |
| assembly processes | |
| ASTM F1980-16 | Standard Guide For Accelerated Aging Of Sterile Barrier |
| Systems For Medical Devices | |
| ISO 10993-1 Fourth | |
| edition 2009-10-15 | Biological evaluation of medical devices - part 1: |
| evaluation and testing within a risk management process | |
| ISO 10993-5 Third edition | |
| 2009-06-01 | Biological evaluation of medical devices - part 5: tests for |
| in vitro cytotoxicity | |
| ISO 10993-10 Third | |
| Edition 2010-08-01 | Biological evaluation of medical devices - part 10: tests |
| for irritation and skin sensitization | |
| ISO 10993-11 Third | |
| edition 2017-09 | Biological evaluation of medical devices - part 11: tests |
| for systemic toxicity | |
| ISO 14971 Second edition | |
| 2007-03-01 | Medical devices - application of risk management to |
| medical devices | |
| ASTM F756 | Standard Practice for Assessment of Hemolytic Properties |
| of Materials | |
| Standard No. | Standard Title |
| ISO 10993-4 | Biological evaluation of medical devices - Part 4: |
| Selection of tests for interactions with blood | |
| USP General Chapter | Pyrogen Test |
| USP 42, NF 37, General | Bacterial Endotoxins Test |
| Chapters | |
| USP 42, NF 37, General | Medical Devices-Bacterial Endotoxin and Pyrogen Tests |
| Chapters |
Table 2 The list of applicable FDA recognized standards
13
7. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
Sterilization/shelf-life testing for the Single Use Guide Sheath Kit and the Single Use Guiding Device were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Prior to the shelf-life testing, simulated distribution tests as well as accelerated aging test were carried out on the test samples of subject device in final finished form.
The real-time aging test for one-year (Single Use Guide Sheath Kit) and three-years (Single Use Guiding Device CC-220DR) to demonstrate the claimed stability and support the results of the accelerated aging test for the subject devices.
Biocompatibility testing for Single Use Guide Sheath Kit and the Single Use Guiding Device were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
Performance testing was carried out to demonstrate the safety and the effectiveness of the subject devices.
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- Radiographic Testing -
- Catheter Joint/Tensile Testing -
- Dimensional Testing -
- Simulated Use Testing -
- Trackability Testing (insertion & withdrawal) -
Risk analysis for the Single Use Guide Sheath Kit and the Single Use Guiding Device was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
8. Conclusion
In comparison to the predicate devices, the Single Use Guide Sheath Kit and the Single Use Guiding Device raise no new safety issues and are substantially equivalent to the predicate device.