(56 days)
Not Found
No
The summary describes a mechanical injection needle used with an endoscope and does not mention any software, algorithms, or data processing that would indicate AI/ML. The performance studies are focused on mechanical properties and fluid delivery.
Yes
The device is used to perform endoscopic vascular or submucosal injection in the GI tract, and this function constitutes a therapeutic intervention.
No
The device is designed to perform endoscopic vascular or submucosal injection, which is a therapeutic intervention, not a diagnostic one. It is used to inject fluid into target tissue, not to gather information for diagnosis.
No
The device description clearly outlines physical components (handle section, needle section, sheath section) and describes physical actions (puncturing tissue, injecting fluid), indicating it is a hardware device. The performance studies also focus on physical characteristics and functions.
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 vascular or submucosal injection in the GI tract." This describes a therapeutic or procedural use within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical instrument used for puncturing tissue and injecting fluid. This aligns with a surgical or procedural tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on the mechanical and functional aspects of the device (inserting, withdrawing, needle performance, injection amount, packaging integrity), which are typical for surgical or procedural instruments, not IVDs.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver a substance into the body, which is a therapeutic or procedural action.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
Product codes
FBK
Device Description
This instrument has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
The subject device consists of a handle section, needle section, and sheath section. The subject device is used to puncture the target tissue where guided by the endoscope. The fluid is injected to the target through the subject device by an injector which is connected the subject 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
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 following performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
-
- Inserting into endoscope
- 2, Withdrawing from endoscope
-
- Advance of tube
- 4, Retraction of tube
- 5, Needle extension length
- 6, Smooth puncturing of the needle
-
- Normal reaction force to needle puncturing.
- 8, Amount of injected fluid
- 9, Needle retraction propriety
- 10, Performance after repeated device operation
- 11, Visual inspection of the package
- 12, Peel strength of the package
- 13, Endurance to splitting of the package
-
- Integrity of the package
Risk analysis was carried out 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.
Biocompatibility testing is performed in accordance with the FDA Guidance," Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
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: K153625
Trade/Device Name: Single Use Injector NM600/610 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: December 16, 2015 Received: December 18, 2015
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. 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 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K153625
Device Name Single Use Injector NM600/610
Indications for Use (Describe)
This instrument has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Image /page/3/Picture/0 description: The image contains the word "OLYMPUS" in large, bold, blue letters. Below the word is a thin, horizontal, yellow line. Under the line, the text "Your Vision, Our Future" is written in a smaller, blue font.
510(k) Summary
K153625 510(k) Summary Page 1 of 5
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510(k) SUMMARY Single Use Injector NM600/610
December 16, 2015
5.1 General Information
| ■ Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan
192-8507
Establishment Registration No: 8010047 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Official Correspondent: | 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 |
| ■ Manufacturer: | Aomori Olympus Co., Ltd.
248-1 Okkonoki 2-chome Kuroishi-shi,
Aomori, Japan 036-0357
Establishment Registration No.: 9614641 |
5.2 Device Identification
| ■ Device Trade Name: | Single Use Injector NM600/610 |
|---|---|
| ■ Common Name: | Injector |
| ■ Regulation Number: | 876.1500 |
| ■ Regulation Name: | Endoscope and accessories |
| ■ Regulatory Class: | II |
| ■ Classification Panel: | Endoscopic Injection Needle, Gastroenterology-Urology |
| ■ Product Code: | FBK |
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Predicate Device Information 5.3
| Device Trade
| Name | Common Name | Applicant | 510(k) No. |
|---|---|---|---|
| Olympus | |||
| Injector | |||
| NM-4-1, | |||
| NM-5-1, | |||
| NM-6-1, | |||
| NM-7-1, | |||
| NM-8-1, | |||
| NM-9-1, | |||
| NM-4U-1, | |||
| NM-4Z-1 | Injector | OLYMPUS OPTICAL Co., | |
| Ltd. | K011484 | ||
| NM Injection | |||
| Needles | Sterile | ||
| Injection | |||
| Needle | OLYMPUS Corporation. | K902736 | |
| Injection | |||
| Needle | Injection | ||
| Needle | ENDOCHOICE, INC. | K132065 |
5.4 Device Description
This instrument has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
The subject device consists of a handle section, needle section, and sheath section. The subject device is used to puncture the target tissue where guided by the endoscope. The fluid is injected to the target through the subject device by an injector which is connected the subject device.
ર. ર Indications for Use
This instrument has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
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Image /page/6/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. A thin, yellow line is underneath the word. Below the line, the words "Your Vision, Our Future" are written in a smaller font.
5.6 Comparison of Technological Characteristics
Compared to the predicate device, the proposed subject device; Single Use Injector NM600/610, has similar technological characteristics. There is no significant difference that affects the safety or effectiveness of the subject device.
5.7 Summary of non-clinical testing
· The following performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
-
- Inserting into endoscope
- 2, Withdrawing from endoscope
-
- Advance of tube
- 4, Retraction of tube
- 5, Needle extension length
- 6, Smooth puncturing of the needle
-
- Normal reaction force to needle puncturing.
- 8, Amount of injected fluid
- 9, Needle retraction propriety
- 10, Performance after repeated device operation
- 11, Visual inspection of the package
- 12, Peel strength of the package
- 13, Endurance to splitting of the package
-
- Integrity of the package
· Risk analysis was carried out 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.
· Biocompatibility testing is performed in accordance with the FDA Guidance," Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1".
The following standards have been applied to the Single Use Injector NM600/610.
·ISO 10993-1 ·ISO 10993-5 ·ISO 10993-10 ·ISO 10993-11 · ASTM F756-13 ·ISO 11135 ·ISO 14971 · ASTM F1980-07
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5.8 Conclusion
When compared to the predicate device, the Single Use Injector NM600/610 does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.