(77 days)
Not Found
No
The description focuses on a mechanical, suture-based system for creating a plication and mentions cleaning/disinfection procedures. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is indicated for the treatment of symptoms of chronic gastroesophageal reflux disease (GERD) and deploys a suture-based implant to create a plication, which are therapeutic actions.
No
The device is an Endoscopic Plication System used for the treatment of chronic gastroesophageal reflux disease (GERD) by creating a plication in the stomach. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines hardware components (Plicator instrument, Plicator retractor, Plicator implant cartridge, cleaning adapter) that are integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of symptoms of chronic GERD by creating a plication in the stomach. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a surgical system used to physically alter tissue within the body. It's a procedural device, not something used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting markers, measuring substances, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The NDO Surgical Endoscopic Plication System (EPS) is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
Product codes
ODE
Device Description
The NDO Surgical Endoscopic Plication System (EPS) deploys a suture-based implant in the stomach near the Gastroesophageal Junction thereby creating a full thickness plication of the gastric cardia for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three procedural components: the Plicator instrument, the Plicator retractor and the Plicator implant cartridge. The implant cartridge and retractor are loaded onto the instrument and the instrument is then passed transorally into the stomach to create the plication.
Both the retractor and implant cartridge are provided as sterile, single use, disposable components of the EPS. The Plicator instrument is a non-sterile multiple use device that is subject to cleaning and high level chemical disinfection between uses. To facilitate cleaning and high level disinfection of the Plicator instrument with an Automated Endoscope Reprocessor (AER), the EPS will include a non-procedural "cleaning adapter" accessory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach near the Gastroesophageal Junction
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)
Automated cleaning and disinfection simulated use testing using Mycobacterium terrae was performed in accordance with ASTM E 1837-96 (Reapproved 2002) -Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Decices (Simulated Use Test) and demonstrated that cleaning and high level disinfection of the Plicator instrument was achievable using CIDEX in a Custom Ultrasonics System 83 Plus™ Endoscope Washer/Disinfector.
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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K072125
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5. 510(K) SUMMARY
OCT 1 8 2007
1. SUBMITTER:
NDO Surgical, Inc. 125 High St. Mansfield, MA 02048 Telephone: 508-337-8881 Fax: 508-337-8882
Contact: John J. Vozella, V.P. Regulatory/Clinical/OA Date Prepared: July 31, 2007
2. DEVICE:
Trade Name: Endoscopic Plication System; Plicatore Common Name: Endoscope accessory Classification Name: Endoscope and accessories Class: II
3. PREDICATE DEVICE:
NDO Surgical Endoscopic Plication System (K071553)
4. DEVICE DESCRIPTION:
The NDO Surgical Endoscopic Plication System (EPS) deploys a suture-based implant in the stomach near the Gastroesophageal Junction thereby creating a full thickness plication of the gastric cardia for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three procedural components: the Plicator instrument, the Plicator retractor and the Plicator implant cartridge. The implant cartridge and retractor are loaded onto the instrument and the instrument is then passed transorally into the stomach to create the plication.
Both the retractor and implant cartridge are provided as sterile, single use, disposable components of the EPS. The Plicator instrument is a non-sterile multiple use device that is subject to cleaning and high level chemical disinfection between uses. To facilitate cleaning and high level disinfection of the Plicator instrument with an Automated Endoscope Reprocessor (AER), the EPS will include a non-procedural "cleaning adapter" accessory.
5. INTENDED USE:
The NDO Endoscopic Plication System (EPS) is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
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K072125
Page 2 of 2
6. COMPARISON OF CHARACTERISTICS:
The proposed Endoscopic Plication System (EPS), is similar in design and materials and identical in fundamental operating principles and intended use to the predicate EPS device (K071553).
Proposed changes to the Plicator® labeling and accessories are as follows:
- . EPS instructions for use have been modified to update cleaning and high level disinfection instructions to permit use of an AER for high level disinfection of the Plicator instrument.
- A scope channel cleaning adapter has been added as an EPS accessory to permit compatible attachment of the Plicator instrument to an AER for cleaning and high level disinfection purposes.
7. PERFORMANCE DATA:
Automated cleaning and disinfection simulated use testing using Mycobacterium terrae was performed in accordance with ASTM E 1837-96 (Reapproved 2002) -Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Decices (Simulated Use Test) and demonstrated that cleaning and high level disinfection of the Plicator instrument was achievable using CIDEX in a Custom Ultrasonics System 83 Plus™ Endoscope Washer/Disinfector.
8. CONCLUSION:
The modified Endoscopic Plication System (EPS) referenced in this submission is equivalent in technology, method of operation and intended use to the predicate (K071553) EPS.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its head, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2007
Mr. John J. Vozella V.P. RA/Clinical/QA NDO Surgical, Inc. 125 High Street. Suite 7 MANSFIELD MA 02048
Re: K072125
Trade/Device Name: Endoscopic Plication System; EPS; Plicator® Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODE Dated: July 31, 2007 Received: August 2, 2007
Dear Mr. Vozella:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT 4.
510(k) Number (if known):__Ko7 2125
Device Name: Endoscopic Plication System; EPS; Plicator®
Indications for Use: The NDO EPS System (Plicator®) is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
Prescription Use __X (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Herbert Penner
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
\\DC - 71403/600 - 0869482.01
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