(230 days)
Not Found
No
The summary describes a mechanical device for delivering injectable materials and does not mention any AI/ML components or capabilities.
Yes
The device is intended to deliver injectable materials into the urinary bladder wall, which is an action meant to treat a condition or restore function, thus classifying it as a therapeutic device.
No
This device is designed to deliver injectable materials into the urinary bladder wall, not to diagnose a condition. It is a therapeutic/interventional device.
No
The device description and performance studies clearly indicate a physical, sterile instrument designed for delivering injectable materials, not a software-only 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 "deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures." This describes a device used in vivo (within the body) for a therapeutic or procedural purpose.
- Device Description: The description reinforces the in vivo use with an endoscope to deliver materials into the bladder wall.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing samples like blood, urine, tissue, etc.
Therefore, this device falls under the category of a surgical or procedural instrument used directly on a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.
Product codes
FBK
Device Description
This instrument has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures. The subject device is sterilized and packaged in a sterilization package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary bladder wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance data were provided in support of the substantial equivalence determination.
- Sterilization/Shelf-life testing: Sterilization/shelf-life testing for the NM-221C-0427 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". Accelerated aging test for the NM-221C-0427 was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three-years will be performed to demonstrate longer stability and support the results of the accelerated aging test.
- Biocompatibility testing: Biocompatibility testing for the NM-221C-0427 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". The Single Use Injector NM-221C-0427 is considered an externally communicating medical device in contact with Tissue/bone/dentin. The contact duration is limited exposure (i.e. contact is up to 24 hours). The biocompatibility testing included the following tests: Cytotoxicity Study Using the Colony Assay, ISO Intracutaneous Study in Rabbits, ISO Guinea Pig Maximization Sensitization Test, ISO Acute Systemic Toxicity Study in Mice, USP Rabbit Pyrogen Study, Material Mediated.
- Performance testing - Bench: Bench testing for the NM-221C-0427 as listed below was conducted to ensure that the subject device performs as intended and meet design specifications: Endoscope compatibility, Needle slidability, Puncture performance, Liquid leakage, Durability, Flow rate (BS EN 1618: 1997 Catheters other than intravascular catheters Test methods for common properties), Corrosion Testing (ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods).
- Performance testing - Animal: No animal study was performed to demonstrate substantial equivalence.
- Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence.
- Risk analysis: Risk analysis for the NM-221C-0427 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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April 28, 2020
Olympus Medical Systems Corp. Sheri Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K192498
Trade/Device Name: Single Use Injector NM-221C-0427 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBK Dated: March 19, 2020 Received: March 20, 2020
Dear Sheri Musgnung:
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.
1
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 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 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.
Martha W. Betz, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Single Use Injector NM-221C-0427
Indications for Use (Describe)
This instrument has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.
Type of Use (Select one or both, as applicable)
| Research Use (Part 81 CFR 801.3 Subject to Review) |
|---|
| Genetic Testing (81.420) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. A registered trademark symbol is located to the right of the letter "S".
March 19, 2020
Single Use Injector NM-221C-0427
Revised 510(k) Summary
1 GENERAL INFORMATION
| ■ 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507,
Japan |
| --------------------- | -------------------------------------------------------------------------------------------- |
|---|
- Contact Person: Sheri L. 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
2 DEVICE IDENTIFICATION
| ■ Device Name | Single Use Injector NM-221C-0427 |
|---|---|
| ■ Common Name | endoscopic injection needle, gastroenterology-urology |
| ■ Regulation Number | 21 CFR 876.1500 |
| ■ Regulation Name | Endoscope and accessories |
| ■ Regulatory Class | II |
| ■ Product Code | FBK |
| ■ Classification Panel | Gastroenterology/Urology |
3 PREDICATE DEVICE
■ Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| BONEE NEEDLE FOR BLADDER | ||
| INJECTIONS NB1070 | COLOPLAST A/S | K090217 |
4
4 DEVICE DESCRIPTION
- General Description of the subject device
This instrument has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures. The subject device is sterilized and packaged in a sterilization package.
Principle of Operation
When the operation portion of the needle section is pushed into the Sheath section, the needle protrudes from the distal end of the sheath section. Pulling the operation portion of the needle section toward the proximal end with respect to the sheath section pulls the needle into the coil sheath. The subject device is inserted into the endoscope in the retracted state. After the subject device reaches the urinary bladder wall, puncture is performed with the needle protruding from the coil sheath. A commercially available marketed syringe (not included in the subject device) is attached to the proximal end of the needle section to deliver injectable materials to the target site of the urinary bladder wall.
5 INDICATIONS FOR USE
This instrument has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.
6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE
The NM-221C-0427 has the same technological characteristics and design as the predicate device except for the following new features:
- Needle design
- Sheath design
- Working length
Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
5
A side by side comparison of the subject device and the predicate device is provided below.
| Subject Device | Predicate Device | |
|---|---|---|
| Item | Single Use Injector | |
| NM-221C-0427 | BONEE NEEDLE FOR | |
| BLADDER INJECTIONS | ||
| NBI070 | ||
| Indications for Use | This instrument has been | |
| designed to be used with an | ||
| Olympus endoscope to | ||
| deliver injectable materials | ||
| into the urinary bladder | ||
| wall during the transurethral | ||
| endoscopic procedures. | The Bonee Needle for | |
| Bladder Injections is used | ||
| to deliver injectable | ||
| materials into the urinary | ||
| bladder wall during the | ||
| transurethral endoscopic | ||
| procedures. | ||
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories | Endoscope and accessories |
| Regulatory Class | II | II |
| Product Code | FBK | FBK |
| Classification Panel | Gastroenterology/Urology | Gastroenterology/Urology |
| Compatible Olympus | ||
| cystoscope | Working length: less than | |
| 380mm | ||
| Channel inner diameter: | ||
| 2.0mm or more | Working length: unknown | |
| Channel inner diameter: 5 | ||
| French(= 1.7mm) or more | ||
| Needle width | 27G | 22G |
| Typical needle length | 4mm | 4mm |
| Maximum insertion portion | ||
| diameter | φ1.84mm | unknown |
| Working length | 971 mm | 700mm |
| Sheath type | Sheath structure: dual | |
| structure (outer: coil sheath, | ||
| inner: tube sheath) | Sheath structure: single | |
| structure (tube sheath only) | ||
| Stylet | Equipped (Diameter: | |
| φ0.3mm, Length: 700mm) | Not equipped | |
| Tip shape of needle | Tip shape: Lancet Point | Tip shape: Unknown |
6
7 PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Sterilization/Shelf-life testing
Sterilization/shelf-life testing for the NM-221C-0427 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".
Accelerated aging test for the NM-221C-0427 was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three-years will be performed to demonstrate longer stability and support the results of the accelerated aging test.
2) Biocompatibility testing
Biocompatibility testing for the NM-221C-0427 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". The Single Use Injector NM-221C-0427 is considered an externally communicating medical device in contact with Tissue/bone/dentin. The contact duration is limited exposure (i.e. contact is up to 24 hours). The biocompatibility testing included the following tests:
- Cytotoxicity Study Using the Colony Assay ।
- ISO Intracutaneous Study in Rabbits ।
- ISO Guinea Pig Maximization Sensitization Test
- ISO Acute Systemic Toxicity Study in Mice
- USP Rabbit Pyrogen Study, Material Mediated ।
3) Performance testing - Bench
Bench testing for the NM-221C-0427 as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Endoscope compatibility
- Needle slidability
- Puncture performance
- Liquid leakage
- Durability
- Flow rate (BS EN 1618: 1997 Catheters other than intravascular catheters Test methods for common properties)
- Corrosion Testing (ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods)
7
Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and have a slightly three-dimensional appearance. A registered trademark symbol is located to the right of the letter "S".
K192498 Page 5 of 5
4) Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
5) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
6) Risk analysis
Risk analysis for the NM-221C-0427 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 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the NM-221C-0427 raise no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, effectiveness and performance.