(147 days)
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI or ML algorithms for image analysis, diagnosis, or treatment planning.
Yes
The device is intended to "endoscopically dilate strictures of the alimentary tract," which is a direct therapeutic action to treat a medical condition.
No
The device is intended to dilate strictures, which is a therapeutic action, not a diagnostic one. While it uses fluoroscopic visualization, this is for guidance during therapy, not for disease detection or analysis.
No
The device description clearly details physical components such as a catheter, balloon, ports, stopcock, and radiopaque bands, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "endoscopically dilate strictures of the alimentary tract." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical catheter with a balloon designed for mechanical dilation. It is used for a physical intervention.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are used to test samples like blood, urine, tissue, etc., to diagnose conditions.
- Input Imaging Modality: While fluoroscopic visualization is used, it's for guiding the placement and inflation of the device during the procedure, not for analyzing images of biological samples.
In summary, the Balloon Dilatation Catheter is a therapeutic medical device used for a physical intervention within the body, not for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Balloon Dilatation Catheter is intended to endoscopically dilate strictures of the alimentary tract. The device is supplied sterile and intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
FDF, KNQ, FDS
Device Description
The proposed device Balloon Dilatation Catheter is comprised of a pebax balloon mounted at the distal end of a pebax catheter with two ports. The balloon can be inflated to three distinct sizes, 6-7-8mm, 8-9-10mm, 10-11-12mm, 12-13.5-15mm, 15-16.5-18mm, 18-19-20mm diameters; the balloon length can be 30mm, 55mm and 80mm. Radiopaque bands placed at the distal and proximal end of the device provide fluoroscopic visualization of the balloon location. The catheter length is 1800mm, 1950mm, 2100mm and 2400mm with an outer diameter of 1.8mm, 2.0mm or 2.3mm. The two ports correspond to a guide wire port and balloon inflation port. A stopcock is included at the proximal end of the balloon inflation port to control pressure movement into or out of the device. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. The Balloon Dilatation Catheter is EO sterilization and use for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
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)
The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
Following tests were conducted in our non-clinical bench test:
- The head tip of the distal end;
- Connect strength;
- Leakage performance;
- Balloon fatigue performance;
- Balloon position detectability;
- Interface compatibility with endoscope;
- Compatibility with guide wire;
- Compatibility with luer taper.
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
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
April 6, 2022
Hangzhou AGS MedTech Co., Ltd. Jiayuan Zhang, RA Specialist Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou. Zhejiang 311106 CHINA
Re: K213578 Trade/Device Name: Balloon Dilatation Catheter Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF, KNQ, FDS Dated: November 4, 2021 Received: November 10, 2021
Dear Jiayuan Zhang:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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 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).
Sincerely,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality 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: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K213578
Device Name Balloon Dilatation Catheter
Indications for Use (Describe)
The Balloon Dilatation Catheter is intended to endoscopically dilate strictures of the alimentary tract. The device is supplied sterile and intended for single use only.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (6/20)
3
K213578 Page 1 of 6
Image /page/3/Picture/1 description: The image shows the logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the logo are the words "AGS MEDTECH" in English, followed by the same name in Chinese characters. The text is in a smaller font size than the logo itself.
510(k) Summary Balloon Dilatation Catheter
510(k) Summary
We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.
5.1 Submitter
| Submitter Information | Hangzhou AGS MedTech Co., Ltd.
Building 5, Building 6, No.597 Kangxin Road Yuhang
District, 311106 Hangzhou, Zhejiang, China | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--|
| Establishment
Registration Number: | 3010288205 | |
| Registration Status: | Active | |
| Contact Person: | Jiayuan Zhang
Phone: 0086-18668235131
Fax: 0086-0571-87671225
Email: zhangjy@bioags.com | |
| Date Prepared: | March 22, 2022 | |
5.2 Proposed Device
| Trade Name: | Not Applicable |
|---|---|
| Device Name: | Balloon Dilatation Catheter |
| Common Name: | Balloon Dilatation Catheter |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR § 876.1500 |
| Regulation Name: | Endoscope and accessories, |
| FDA Review Panel: | Gastroenterology/Urology |
| Product Code(s): | FDF, KNQ, FDS |
| Product Code Name: | FDF: Colonoscope And Accessories, |
| FDS: Gastroscope And Accessories, | |
| KNQ: Dilator, Esophageal |
5.3 Predicate Device
| Trade Name: | CRE™ Balloon Dilation Catheter |
|---|---|
| Common Name: | Dilation catheter |
| 510(k) Number: | K110833 |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR § 876.1500 |
| Regulation Description: | Endoscope and accessories |
| FDA Review Panel: | Gastroenterology/Urology |
| Product Code(s): | FDT, FDF, KNQ |
| Product Code Name: | FDT: Duodenoscope And Accessories, Flexible/Rigid |
| FDF: Colonoscope And Accessories, Flexible/Rigid | |
| KNQ: Dilator, Esophageal |
4
Image /page/4/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a blue and green circular design on the left, with the text "AGS MEDTECH" in black on the right. Below the English text is the same text in Chinese characters. The logo is simple and modern, and the colors are bright and eye-catching.
K213578 Page 2 of 6
510(k) Summary Balloon Dilatation Catheter
5.4 Device Description
The proposed device Balloon Dilatation Catheter is comprised of a pebax balloon mounted at the distal end of a pebax catheter with two ports. The balloon can be inflated to three distinct sizes, 6-7-8mm, 8-9-10mm, 10-11-12mm, 12-13.5-15mm, 15-16.5-18mm, 18-19-20mm diameters; the balloon length can be 30mm, 55mm and 80mm. Radiopaque bands placed at the distal and proximal end of the device provide fluoroscopic visualization of the balloon location. The catheter length is 1800mm, 1950mm, 2100mm and 2400mm with an outer diameter of 1.8mm, 2.0mm or 2.3mm. The two ports correspond to a guide wire port and balloon inflation port. A stopcock is included at the proximal end of the balloon inflation port to control pressure movement into or out of the device. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. The Balloon Dilatation Catheter is EO sterilization and use for single use only.
5.5 Indication for Use statement
The Balloon Dilatation Catheter is intended to endoscopically dilate strictures of the alimentary tract. The device is supplied sterile and intended for single use only.
5.6 Comparison of Technology Characteristics
Our proposed device Balloon Dilatation Catheter is substantially equivalent to the predicate devices. The differences between the Balloon Dilatation Catheter and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below:
5
Image /page/5/Figure/0 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green shape in the center. To the right of the circular design, the text "AGS MEDTECH" is written in a smaller font size. Below that, there is Chinese text that translates to "An Jie Si Medical".
Table 5.6 Comparison of technical characteristics
| Item | Proposed device | Predicate device | Comparison | |
|---|---|---|---|---|
| Trade name | Not applicable | CRETM Wireguided Balloon Dilatation | ||
| Catheter | / | |||
| Model number | 5251 series, 5252 series | M00558500*****, M00558450, | ||
| M00558460, M00558470, M00558480, | ||||
| M00558490 | ||||
| M00558390, M00558400, M00558410, | ||||
| M00558420, M00558430, | ||||
| M00558440**** | / | |||
| 510(k) submitter | Hangzhou AGS MedTech | |||
| Co., Ltd. | Boston Scientific | |||
| Corporation | / | |||
| 510(k) number | K213578 | K110833 | / | |
| Clinical | Intended use | The Balloon Dilatation Catheter is intended | ||
| to endoscopically dilate strictures of the | ||||
| alimentary tract. The device is supplied | ||||
| sterile and intended for single use only. | Indicated for use in adult and adolescent | |||
| populations to endoscopically dilate | ||||
| strictures of the alimentary tract. The | ||||
| recommended application is printed on the | ||||
| package label referring to any combination | ||||
| of esophageal, pyloric and colonic dilatation. | Similar. Our proposed device has the | |||
| smaller applicable population range. | ||||
| Applicable | ||||
| population | Adults | Adult and adolescent populations | Different. Our proposed device | |
| has the smaller applicable | ||||
| population | ||||
| range. | ||||
| Principles | ||||
| of | ||||
| operation | Balloon Dilatation Catheter is a device that | |||
| operated on the principle of inflating a | ||||
| balloon attached to the distal end of | ||||
| catheter, to dilate strictures of the | ||||
| alimentary tract. Radiopaque bands placed | ||||
| at the distal and proximal ends of the | ||||
| balloon provide fluoroscopic visualization | ||||
| of the balloon location. | ||||
| The Balloon Dilatation Catheter is capable | ||||
| of 3 distinct and progressively larger size | ||||
| diameters via controlled radial expansion. | ||||
| Specific balloon sizes are printed on each | ||||
| package and small label. | The CRE Wireguided Balloon Dilatation | |||
| Catheter is capable of 3 distinct and | ||||
| progressively larger size diameters via | ||||
| controlled radial expansion. Specific balloon | ||||
| sizes are printed on each package and hub | ||||
| label. | Similar. | |||
| Rapid exchange | ||||
| or not | For 5251 Series : No |
For 5252 series: Yes | No | Different. We use K172520 as
reference device to support this
technological characteristic. |
| Technical | Device
picture and
structure | Drawing of Balloon Dilatation Catheter (for
5251 series)
Image: Drawing of Balloon Dilatation Catheter
1.Guide
wire port
3.Balloon
inflation
5.Catheter
7.Balloon
2. On-off valve
4.Base port
6. Small label
8.Radiopaque
band | Image: Device picture and structure | Similar |
| | | Drawing of Balloon Dilatation Catheter (for 5252 | | |
| | | series) | | |
| | | Image: Drawing of a balloon dilatation catheter | | |
| | | 1. Guide
wire port
inflation
5.Catheter
7.Balloon
9.Luer cap | 2.On-off
valve 3.Balloon
4.Base port
6.Small
label
8.Radiopaque band
10.RX
support wire | |
| | | | | |
| | Outer diameter | 1.8mm, 2.0mm, 2.3mm | 2.5mm (7.5Fr) | Similar. |
| | Balloon length | 30mm, 55mm, 80mm; | 55mm | Similar.
Our proposed device has more
specifications to be chosen. |
| | Working length | 1800mm, 1950mm,
2100mm, 2400mm | 2400mm, 1800mm | Similar.
Our proposed device has more
specifications to
be chosen. |
| | Suitable working
channel of
endoscope | For 5252 series: 3.7 mm | 2.8 mm | Different. We use K172520, K112994 and
K122924 as reference devices to support
this technological characteristic. |
| Biological | Materials or
substances in
contact with the
same human
tissue or body
fluids | PEBAX | No exact information. | Different. Biocompatibility tests have
been done for the difference.
Biological risks are acceptable. |
| | Biocompatibility | In Vitro Cytotoxicity Test: ISO 10993-5: 2009;
Skin sensitization Test: ISO | No exact information. | |
| | | | | |
Section 5 510(k) Summary
Balloon Dilatation Catheter
6
Image /page/6/Picture/2 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the circular design, the text "AGS MEDTECH" is written in a sans-serif font. Below "AGS MEDTECH", there is Chinese text.
Section 5 510(k) Summary
Balloon Dilatation Catheter
7
Image /page/7/Picture/0 description: The image shows the logo for AGS Medtech. The logo consists of a blue and green circular design on the left, with the text "AGS MEDTECH" in black on the right. Below the English text is the same name in Chinese characters. The logo is simple and modern, and the colors are bright and eye-catching.
Section 5 510(k) Summary
Balloon Dilatation Catheter
8
Image /page/8/Picture/0 description: The image shows a logo for AGS MEDTECH. The logo consists of a blue circular design with three curved arrows pointing inward, with a green shape in the center. To the right of the circular design, the text "AGS MEDTECH" is written in English, with the Chinese characters for "Anjie Si Medical" written below.
K213578 Page 6 of 6
Section 5 510(k) Summary Balloon Dilatation Catheter
| 10993-10: 2010; | ||
|---|---|---|
| Intracutaneous Reactivity | ||
| Test: ISO 10993-10: 2010; | ||
| Acute Systemic Toxicity Test: | ||
| ISO 10993-11:2017; | ||
| Pyrogenicity: ISO | ||
| 10993-11:2017; | ||
5.7 Applicable Guidance Document
NA
5.8 Performance Data
The Balloon Dilatation Catheter meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
Following tests were conducted in our non-clinical bench test:
- The head tip of the distal end;
- Connect strength; ●
- Leakage performance; ●
- Balloon fatigue performance;
- Balloon position detectability; ●
- . Interface compatibility with endoscope;
- Compatibility with guide wire;
- . Compatibility with luer taper.
5.9 Clinical Test
No Clinical test is included in this submission.
5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS MedTech Co., Ltd has demonstrated that proposed device Balloon Dilatation Catheter is substantially equivalent to the predicate devices.