(266 days)
No
The device description and performance studies focus on the mechanical aspects of a cytology brush for cell collection, with no mention of AI or ML for analysis or processing.
No.
The device is used for collecting specimens for diagnostic examination, not for treating a disease or condition.
No
The device is designed to collect specimens or cells for cytologic examination, not to perform the examination or provide a diagnosis itself. It is a tool for specimen collection, which is part of a diagnostic process, but not the diagnostic device.
No
The device description clearly outlines physical components (brush head, handle, bristles, steel wire, etc.) and performance testing related to these physical attributes (tensile strength, push ability, tissue sampling performance), indicating it is a hardware 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 "collect specimens or cells endoscopically for cytologic examination". This describes a specimen collection device, not a device that performs a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description details a physical tool (brush) designed to be inserted into the body to gather cells. It does not describe reagents, test kits, or analytical equipment used to analyze a sample.
- Lack of Diagnostic Function: The device's function is solely to obtain the sample. The diagnostic examination (cytologic examination) is performed after the sample is collected, likely using other methods and equipment.
IVD devices are typically used to perform tests on samples (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions. This cytology brush is a tool used before any in vitro diagnostic testing would occur.
N/A
Intended Use / Indications for Use
The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes. Intended patient population: Adults
Product codes (comma separated list FDA assigned to the subject device)
BTG
Device Description
The Disposable Cytology Brush is a sterile, single-use device as a kind of accessories for bronchial endoscopy. The Disposable Cytology Brush is intended to be used in conjunction with a bronchoscope to collect cells from the bronchi.
The Disposable Cytology Brush is designed to insert through suitable endoscope's accessory channel to collect cells from the bronchi.
The Disposable Cytology Brush mainly consists of brush head part and handle part. The brush head is composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/ pull rod.
The Disposable Cytology Brush has two different models depending on different design of the brush head. The WB series is a cytology brush with straight type of brush head and the XA series is a cytology brush with oval type of brush head. Each model has different specifications depending on different working length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bronchi
Indicated Patient Age Range
Adults
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)
Non-clinical testing for Disposable Cytology Brush was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed: Biocompatibility (MTT Cytotoxicity Test, Skin Sensitization Test, Skin Irritation Test, Acute Systemic Toxicity Test and Pyrogen Test conforming to ISO 10993 standards), Sterilization Validation (conforming to ISO 11135, ISO 11737-2, ISO 10993-7, and USP ), Shelf Life and Sterile Barrier System (conforming to ASTM F1980, ISO 11607-1, ISO 11607-2, ASTM F 1929, ASTM D 3078, DIN 58593-6, ASTM F88/F88M, and ASTM D4169), and Performance Data – Bench tests (Appearance, Size and Dimension, Bronchoscope Compatibility, Brush Bond Strength, Tensile Strength, Push ability and Actuation, Tissue Sampling Performance). The performance tests were implemented on both the subject device (Alton Disposable Cytology Brush) and the predicate device (Olympus Single Use Cytology Brush BC-205D) to demonstrate substantial equivalence according to the specific product specification. No animal or clinical studies were available for the subject device.
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.
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.
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
March 4, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alton (Shanghai) Medical Instruments Co. Ltd Wei Song Project Engineer No.24 Building Jinshao Rd.1688.Baoshan District Shanghai, Shanghai 200949 China
Re: K241679
Trade/Device Name: Disposable Cytology Brush (AF series) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: BTG Dated: January 27, 2025 Received: January 27, 2025
Dear Wei Song:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).
2
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Disposable Cytology Brush (AF series)
Indications for Use (Describe)
The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes.
Intended patient population: Adults
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)
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4
510(k) Summary
I. SUBMITTER
Name: Alton (Shanghai) Medical Instruments Co. Ltd.
Address: No.24 Building, JinShao Rd. 1688, Baoshan District, 200949 Shanghai, P. R.
China
Name of contact person: Vivian Li
Position: Director of Quality Department
Tel: +86 21 56771811
Fax: +86 21 66307823
Mail: vivian@alton.com.cn
Date prepared: 2025-02-28
II. Identification of Subjective Device
Device trade name: Disposable Cytology Brush Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulation number: 21 CFR 874.4680 Regulation class: 2 Product Code Description: brush, biopsy, bronchoscope (non-rigid) Product code: BTG
III. Identification of Predicate device Primary predicate device
Predicate Submission Number: K190293 Trade/Device Name: Single Use Cytology Brush BC-205D Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulation Number: 21 CFR 874.4680 Regulatory Class: 2 Product Code Description: brush, biopsy, bronchoscope (non-rigid) Product Code: BTG
5
Reference Device
Predicate Submission Number: K780872 Trade/Device Name: Cytology Brush Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulation Number: 21 CFR 874.4680 Regulatory Class: 2 Product Code Description: brush, biopsy, bronchoscope (non-rigid) Product Code: BTG
IV. Device description
The Disposable Cytology Brush is a sterile, single-use device as a kind of accessories for bronchial endoscopy. The Disposable Cytology Brush is intended to be used in conjunction with a bronchoscope to collect cells from the bronchi.
The Disposable Cytology Brush is designed to insert through suitable endoscope's accessory channel to collect cells from the bronchi.
The Disposable Cytology Brush mainly consists of brush head part and handle part. The brush head is composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/ pull rod.
The Disposable Cytology Brush has two different models depending on different design of the brush head. The WB series is a cytology brush with straight type of brush head and the XA series is a cytology brush with oval type of brush head. Each model has different specifications depending on different working length.
V. Indication for use
The disposable cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes.
Intended patient population: Adults
VI. Comparison of technological characteristics with the predicate/reference device
6
| Attribute | Subject device | Predicative device (K190293) | Reference device (K780872) | Discussion/Conclusion | |
|---|---|---|---|---|---|
| Manufacturer | Alton (Shanghai) Medical Instruments Co. Ltd | Olympus Medical Systems Corp. | COOPERVISION, INC. | / | |
| Trade name | Disposable Cytology Brush | Single Use Cytology Brush BC-205D | CYTOLOGY BRUSH | / | |
| Regulation name | Bronchoscope (Flexible Or Rigid) And Accessories | Bronchoscope (Flexible Or Rigid) And Accessories | Bronchoscope (Flexible Or Rigid) And Accessories | Same | |
| Regulatory Class | II | II | II | Same | |
| Product code | BTG | BTG | BTG | Same | |
| Clinical characteristics | |||||
| Indications for use | The disposable cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes. | The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with Olympus bronchoscopes with channel φ 1.7mm or larger . | The device is intended to be used through endoscopes for the purpose of collecting sterile, non-contaminated specimens for microbiological analysis. | Same | |
| General technological characteristics | |||||
| Device composition | The Disposable Cytology Brush mainly consists of brush head part and handle part. The brush head is | The main component of the proposed device is Brush Head, Outer Sheath and Handle. | Not publicly available | Same | |
| Attribute | Subject device | Predicative device (K190293) | Reference device (K780872) | Discussion/Conclusion | |
| composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/pull rod. | The brush head is composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/pull rod. | ||||
| Principle of Operation | the subject device is inserted into bronchoscope channel to collect specimens with the brush which is equipped at the distal end of the subject device. Then users withdraw the subject device from bronchoscope channel and collect samples for cytology examination. | the subject device is inserted into bronchoscope channel to collect specimens with the brush which is equipped at the distal end of the subject device. Then users withdraw the subject device from bronchoscope channel and collect samples for cytology examination. | Same as predicate device | Same | |
| Mechanics of action | Manual operated | Manual operated | Same as predicate device | Same | |
| Mode of action | brush rotation | brush rotation | Same as predicate device | Same | |
| Maximum insertion portion diameter | $φ$ 1.8 mm | $φ$ 1.4 mm | $φ$ 1.8 mm | Different, see discussion 1 | |
| Working length | 1000 mm, 1200 mm | 1150 mm | 900 mm | Different, see discussion 2 | |
| Brush diameter | AF-D1810WB/AF-D1812WB | $φ$ 2 mm | $φ$ 1.0 mm | AF-D1810WB/AF-D18 | |
| Attribute | Subject device | Predicative device (K190293) | Reference device (K780872) | Discussion/Conclusion | |
| : φ 2 mm | |||||
| AF-D1810XA/AF-D1812XA: | |||||
| φ 4 mm | 12WB: same | ||||
| AF-D1810XA/AF-D18 | |||||
| 12XA: Different, see | |||||
| discussion 3 | |||||
| Brush length | 10 mm | 10mm | Not publicly disclosed | Same | |
| Components | |||||
| material | Brush core: SUS304 | ||||
| Bristles on brush head: Nylon | |||||
| Sheath (tube): PTFE (Teflon) | |||||
| Handle: ABS | Tube: single-layer high density | ||||
| polymer | |||||
| Distal tip/Wire: stainless steel | |||||
| Brush: nylon | |||||
| Handle: not identified | Tube: two-layer Teflon | ||||
| catheter | |||||
| Plug: non-toxic water | |||||
| soluble wax | |||||
| Distal tip/Wire: not | |||||
| identified | |||||
| Brush: not identified | Different, see | ||||
| discussion 4 | |||||
| Sterilization | Method: Ethylene Oxide | ||||
| sterilization | |||||
| SAL: 10-6 | Method: Ethylene Oxide | ||||
| sterilization | |||||
| SAL: 10-6 | Same as predicate device | Same | |||
| Single use/reuse | For single use | For single use | For single use | Same | |
| Shelf life | 3 years | Not publicly disclosed | Not publicly disclosed | Different, see | |
| discussion 5 |
7
8
9
| Attribute | Subject device | Predicative device (K190293) | Reference device
(K780872) | Discussion/Conclusion | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------|
| Mechanical
performance | 1) Dimension
2) Brush Bond Strength
3) Tensile Strength
4) Bronchoscope
Compatibility
5) Push ability and Actuation
6) Tissue Sampling
Performance | 1) Brush operation with the
compatible endoscope
2) Dimension of each part of
the brush
3) General durability
4) Joint/tensile strength | Not publicly disclosed | Same | |
| | Biocompatibility | Cytotoxicity
Skin Sensitization
Skin Irritation Test
Acute Systemic Toxicity Test
Pyrogen Test
Comply with ISO 10993
standards | Cytotoxicity
Skin Sensitization
Skin Irritation Test
Acute Systemic Toxicity Test
Pyrogen Test
Comply with ISO 10993
standards | Not publicly disclosed | Same |
10
Discussion on differences between the subject device and the predicate device
Discussion 1: there are difference on specification of maximum insertion portion diameter between both models, while considering specification of φ 1.8 mm on the subject device is same as the reference device cleared on K780872 manufactured by CooperVision, such differences will not affect clinical performance and safety of the subject device.
Discussion 2: there are two working length specification (1000 mm, 1200 mm) for the subject device, different from specification (1150 mm)for the predicate device, while considering specification of 900 mm is available on the reference device cleared on K780872 manufactured by CooperVision, specification of 1000 mm on the subject device is between the range of 1150 mm on the predicate device and 900 mm on the reference device, 1200 mm on the subject device is quite closer to 1150 mm on the predicate device. In addition, performance test comparison between the subject device and the predicate device is carried out according to specific product technical specification and the test results demonstrate substantial equivalence between subject device and predicate device. Therefore, such differences will not affect clinical performance and safety of the subject device.
Discussion 3: There are two specifications (φ2 mm and φ4 mm) related to brush for diameter AF-D1810WB/AF-D1812WB is φ 2 mm, same as specifications (φ2 mm) for the predicate device. while specification for models AF-D1810XA/AF-D1812XA φ 4 mm. while considering the mechanical performance tests were carried out on both the subject device and the predicate device according to specific product technical specification and the test results demonstrate substantial equivalence between subject device and predicate device. Therefore, such differences will not affect clinical performance and safety of the subject device.
Discussion 4: the tube material used in the subject device is Teflon, different from the tube material used in the predicate device (high density polymer). While considering the tube material used in the subject device is same as reference device cleared on K780872 manufactured by CooperVision, such differences will not affect clinical page 8 of 11
11
performance and safety of the subject device.
Discussion 5: Although shelf life between the subject device and the predicate device is different, sterile process validation and shelf-life validation including performance test are performed on the subject device according to relevant standards, such differences will not affect the safety and effectiveness of the subject device.
VII. Summary of substantial equivalence discussion
Based on the above comparison table as well as discussion on differences, the subject device and the predicate device have similar design features and performance specifications. Although there are some differences on size specification parameters (e.g. maximum insertion portion diameter, brush diameter, working length and tube material) on the subject device and predicate device, such differences will not affect the effectiveness and safety of the subject device. In addition, a performance comparison testing between the subject device and the predicate device is implemented and all mechanical performances are verified to confirm the performance of the subject device is substantially equivalent to the predicate device. These technological differences between the subject device and the predicate device do not affect the safety and effectiveness of the subject device when used as labeled.
VIII. Summary of Non-clinical Data
Non-clinical testing for Disposable Cytology Brush was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed.
A Biocompatibility
The biocompatibility evaluation for the Disposable Cytology Brush was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
- . MTT Cytotoxicity Test: ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity
12
- Skin Sensitization Test: ISO 10993-10:2021, Biological evaluation of ● medical devices - Part 10: Tests for irritation and sensitization
- Skin Irritation Test: ISO 10993-23:2021. Biological evaluation of medical . devices - Part 23: Tests for irritation
- Acute Systemic Toxicity Test and Pyrogen Test: ISO 10993-11:2017 . Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
Sterilization Validation
The EO sterilization of the Disposable Cytology Brush has been validated according to the following applicable standards:
- ISO11135:2014+A1:2018 Sterilization of medical device- validation and . routine control of ethylene oxide sterilization
- . ISO 11737-2:2019 Sterilization of Medical Device-Microbiological methods-part 2: Tests of sterility performed in the validation of a sterilization process
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: . Ethylene oxide sterilization residuals
- . USP Bacterial endotoxins test
- A Shelf Life and Sterile Barrier System
Shelf Life and Sterile Barrier System of the Disposable Cytology Brush has been validated according to the following applicable standards:
- . ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- . ISO11607-1:2019 Packaging for terminally sterilized Medical Device Part 1: Requirement for materials, sterile barrier systems and packaging systems
- . ISO11607-2:2019 Packaging for terminally sterilized Medical Device Part 2: Validation Requirement for forming, sealing and assembly process
- ASTM F 1929-15: Standard Test Method for Detecting Seal Leaks in Porous ● Medical Packaging by Dye Penetration
- ASTM D 3078-02(2013): Standard Test Method for Determination of Leaks . in Flexible Packaging by Bubble Emission page 10 of 11
13
- DIN 58593-6: 2016 Sterilization Sterile Supply Part 6: Microbial Barrier ● Testing of Packaging Materials for Medical Devices Which Are to Be Sterilized
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible . Barrier Materials
- ASTM D4169-16 Standard practice for performance testing of shipping . containers and systems (DC-13, Level II)
- A Performance Data – Bench
The performance tests were implemented on both the subject device (Alton Disposable Cytology Brush) and the predicate device (Olympus Single Use Cytology Brush BC-205D) to demonstrate substantial equivalence according to the specific product specification with the following test items:
- Appearance
- Size and Dimension
- . Bronchoscope Compatibility
- . Brush Bond Strength
- . Tensile Strength
- . Push ability and Actuation
- . Tissue Sampling Performance
-
Performance Data – Animal
N/A, no animal studies are available for the subject device.
IX. Summary of Clinical Data
N/A, no clinical studies are available for the subject device.
X. Conclusions
In conclusion, intended use of the subject device substantially equivalent to the predicate device quoted above. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device is substantially equivalent to the legally marketed predicate device.