(207 days)
No reference devices were used in this submission.
No
The description focuses on the mechanical function of a manually-operated injection needle and does not mention any AI/ML components or capabilities.
Yes
The device is used to perform endoscopic injections for the treatment of conditions like esophageal and gastric varices, which are therapeutic interventions.
No
The device is described as an injection needle used for therapeutic purposes (e.g., treating varices, dye marking) in conjunction with an endoscope, not for diagnosing conditions.
No
The device is a physical, manually-operated needle intended for injection during endoscopy. The description clearly outlines its material properties, shape, and function as a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform endoscopic injections in vivo (within the body) for therapeutic and marking purposes. This is a procedural device used during a medical procedure on a patient.
- Device Description: The description details a physical, manually-operated device designed to be inserted into the body via an endoscope. It performs mechanical functions (injection).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. It does not analyze biological samples like blood, urine, or tissue samples in a laboratory setting.
IVD devices are typically used to test samples taken from the body to diagnose or monitor conditions. This device is used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
It is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
It is a flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform needle functions (e.g., injection) during endoscopy. It is designed with appropriate shape, materials and gauge to function through the working channel of an endoscope. This is a single-use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/hospital
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)
Performance testing was conducted on the following items to support the marketing claims and to confirm that the safety and effectiveness of the subject device is at least equivalent to the predicate device.
- Appearance
- Cleanliness
- Leakage
- Puncture force
- Stiffness
- Resistance of needle tube to breakage
- Corrosion resistance of needle tube
- Particle contamination
- Flexible properties
- Flow
- Compatibility and performance with endoscopes
- Luer lock hub
The EO residual and ECH residual were measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and AAMI/ANSI/ISO 10993-7:2008(R)2012.
The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 and ISO 11607-2 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
Biocompatibility was tested by the third GLP laboratory following ISO 10993-1:2018.
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.
No reference devices were used in this submission.
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.
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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 4, 2024
Promisemed Hangzhou Meditech Co., Ltd. Yang Zearou Regulatory Affairs Manager No. 1388 Cangxing Street Cangqian Community, Yuhang District Hangzhou City, 311121 China
Re: K240675
Trade/Device Name: Endoscopic Injection Needles Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FBK Dated: September 6, 2024 Received: September 6, 2024
Dear Yang Zearou:
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 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).
2
Sincerely,
Shanil P. Haugen -S
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
3
Indications for Use
Submission Number (if known)
Device Name
Endoscopic Injection Needles
Indications for Use (Describe)
It is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.
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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Image /page/4/Picture/0 description: The image shows the logo for Promisemed. The word "Promise" is in blue, except for the "P" which is in green. Above the "om" in "Promise" is a green circle connected to a blue circle by a blue line. To the right of the word "Promisemed" is the registered trademark symbol.
510(k) Summary
Date prepared: 2024-03-08
| 1. Manufacturer[21 CFR 807.92 (a) (1)] | |
|---|---|
| Name | Promisemed Hangzhou Meditech Co., Ltd. |
| Address | No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China. |
| Contact Person | Zearou Yang |
| Phone | +86 571 88772985 |
| Fax | +86 571 88772985 |
| zearou.yang@promisemed.ca | |
| 2. Device [21 CFR 807.92 (a) (2)] | |
| Name | Endoscopic Injection Needles |
| Common Name | Endoscopic Injection Needles |
| Classification Name | Endoscope and accessories |
| Regulation Number | 876.1500 |
| Class | Class II |
| Product Code | FBK |
| 3. Legally Marketed Predicate Device[21 CFR 807.92 (a) (3)] | |
| Predicate Name | Single Use Injection Needle |
| 510(k) Number | K210917 |
| Product Code | FBK |
| Reference Devices | No reference devices were used in this submission. |
| 4. Device Description [21 CFR 807.92 (a) (4)] | |
| It is a flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform needle functions (e.g., injection) during endoscopy. It is designed with appropriate shape, materials and gauge to function through the working channel of an endoscope. | |
| This is a single-use device. | |
| 5. Indication for use [21 CFR 807.92 (a) (5)] | |
| It is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the |
treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.
Indications for Use Comparison [21 CFR 807.92 (a) (5)] 6.
No difference.
5
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.
Comparison of Technological Characteristic [21 CFR 807.92 (a) (6)] 7.
Compared with the predicate device, the subject device is identical in mechanism of action, materials, dimension, sterilization method and biocompatibility. The subject device has the same performance specifications except for Outer sheath diameter, Minimal working channel and working length. Through performance bench testing, the subject device and the predicate device demonstrated to be substantially equivalent. At a high level, the subject and predicate devices are based on the following same technological elements:
| Specification | Subject Device | Predicate Device(K210917) | Discussion of difference |
|---|---|---|---|
| Trade Name | Endoscopic Injection | ||
| Needles | Single Use Injection Needle | Discussion of difference | |
| Manufacturer | Promisemed Hangzhou | ||
| Meditech Co., Ltd. | Anrei Medical (Hangzhou) | ||
| Co., Ltd. | |||
| Device Class | Class II | Class II | No difference |
| Product Code | FBK | FBK | No difference |
| Regulation number | 21 CFR 876.1500 | 21 CFR 876.1500 | No difference |
| Prescription/over- | |||
| the-counter use | Prescription | Prescription | No difference |
| Indications for Use | It is to be used in conjunction | ||
| with an endoscope to | |||
| perform endoscopic | |||
| injections, such as for the | |||
| treatment of esophageal and | |||
| gastric varices and for | |||
| submucosal dye marking in | |||
| the GI tract. | It is to be used in conjunction | ||
| with an endoscope to | |||
| perform endoscopic | |||
| injections, such as for the | |||
| treatment of esophageal and | |||
| gastric varices and for | |||
| submucosal dye marking in | |||
| the GI tract. | No difference | ||
| Environment of use | Healthcare facility/hospital | Healthcare facility/hospital | No difference |
| Single Use | Yes | Yes | No difference |
| Performance | |||
| Needle tube size | 21G, 23G, 25G | 21G, 23G, 25G | No difference |
| Needle tube length | 4mm, 6mm | 4mm, 6mm | No difference |
| Outer sheath | |||
| diameter | 1.8mm, 2.4mm | 2.4mm | Difference. |
| Within the range. | |||
| It does not introduce | |||
| any new concerns for | |||
| safety or efficacy which | |||
| has been confirmed | |||
| performance testing. | |||
| Minimal working | |||
| channel | $Φ2.0mm$ or $Φ2.8mm$ | $Φ2.8mm$ | Difference. |
| Within the range. | |||
| It does not introduce any | |||
| new concerns for safety | |||
| or efficacy which | |||
| has been confirmed | |||
| performance testing. | |||
| Working length | 1200mm, 1800mm, 2000mm, | ||
| 2300mm, 2700mm. | 1800mm, 2000mm, 2300mm. | Difference. | |
| More specifications. | |||
| It does not introduce any | |||
| new concerns for safety | |||
| or efficacy which has | |||
| been confirmed | |||
| performance testing. | |||
| Patient-contact | |||
| potential | |||
| (Duration | |||
| and type of | |||
| contact) | Externally communicating | ||
| medical devices in contact | |||
| with tissue. The contact | |||
| duration is limited exposure | |||
| (i.e. contact is up to 24 | |||
| hours). | Externally communicating | ||
| medical devices in contact | |||
| with tissue. The contact | |||
| duration is limited exposure | |||
| (i.e. contact is up to 24 | |||
| hours). | No difference | ||
| Sterility (SAL of 10-6) | Yes | Yes | No difference |
| Sterilization | |||
| method | Ethylene Oxide | Ethylene Oxide | No difference |
| Biocompatibility | ISO 10993-4:2017, | ||
| ISO 10993-5:2009, | |||
| ISO 10993-10:2021, | |||
| ISO 10993-11:2017, | |||
| ISO 10993-23:2021, | |||
| USP , 2017 | Comply with ISO 10993 | ||
| standards | The biocompatibility | ||
| testing for subject device | |||
| has been tested in | |||
| accordance with the ISO | |||
| 10993-1: 2018, and | |||
| results are qualified. |
6
Image /page/6/Picture/1 description: The image shows the logo for "Promisemed". The word "Promise" is in green, and the word "med" is in blue. There is a blue molecular structure above the "o" in "Promise", and a registered trademark symbol in the upper right corner of the image.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.
Nonclinical test [21 CFR 807.92 (b) (1)] 8.
Performance testing was conducted on the following items to support the marketing claims and to confirm that the safety and effectiveness of the subject device is at least equivalent to the predicate device.
- Appearance —
- Cleanliness ー
- -Leakage
- Puncture force -
- -Stiffness
- -Resistance of needle tube to breakage
- Corrosion resistance of needle tube
- -Particle contamination
- Flexible properties
- -Flow
- -Compatibility and performance with endoscopes
- -Luer lock hub
- Etc. —
The EO residual and ECH residual were measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and AAMI/ANSI/ISO 10993-7:2008(R)2012.
The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 and ISO 11607-2 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
Biocompatibility was tested by the third GLP laboratory following ISO 10993-1:2018;
Clinical test [21 CFR 807.92 (b) (2)] 9.
No clinical test is included in this submission.
7
Image /page/7/Picture/1 description: The image shows the logo for "Promisemed". The word "Promise" is in green and blue, with a green atom-like structure above the "o". The word "med" is in blue, and there is a registered trademark symbol to the right of the word.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.
- Conclusion [21 CFR 807.92 (b) (3)]
Based on the information provided within this 510(k) submission, the subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.