(202 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical device for creating a plication and does not mention any AI or ML components or functions.
Yes
The device is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD), which is a condition that is being treated or managed.
No
The device description clearly states its purpose is for "treatment of the symptoms of chronic gastroesophageal reflux disease (GERD)," not for diagnosing conditions. It involves creating a plication and securing a suture, which are therapeutic actions.
No
The device description explicitly lists hardware components (instrument, retractor, overtube, implant) and the performance studies include mechanical and in-vitro evaluations, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Description: The NDO EPS System is a surgical device used inside the body (in vivo) to create a plication near the gastroesophageal junction. It is a physical instrument used for a therapeutic procedure, not a test performed on a sample.
- Intended Use: The intended use is for the treatment of symptoms of GERD, not for the diagnosis or detection of a condition through analysis of a biological sample.
Therefore, the NDO EPS System falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to phamacological therapy.
Product codes
ODE, GAW, KOG
Device Description
The Endoscopic Plication System consists of an instrument, retractor, overtube and implant.
The instrument is passed transorally to create a plication in close proximity to the gastroesophageal junction.
The implant is designed to help pass and secure the suture.
The retractor is designed to secure and retract the tissue during the placement of the implant. It is placed down a working channel of the instrument prior to the procedure.
The overtube is designed to protect the esophagus during the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The following performance data was provided in support of the substantial equivalence determination:
- . Mechanical evaluation
- In-Vivo safety study ●
- . In-Vitro evaluation
- Clinical evaluation .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird, with its wings forming a human profile. The overall design is simple and professional, conveying a sense of authority and trustworthiness.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NDO Surgical, Inc. Mr. Eric Bannon Vice President of Regulatory, Clinical and Quality Assurance 125 High Street, Suite 7 Mansfield, MA 02048
JUL 2 7 2015
K023234 Re:
Trade/Device Name: Endoscopic Plication System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODE, GAW Dated (Date on orig SE Itr): January 31, 2003 Received (Date on orig SE ltr): February 3, 2003
Dear Mr. Bannon,
This letter corrects our substantially equivalent letter of April 17, 2003.
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
1
Page 2 -
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-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 Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Benjamin R. Fisher -S
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
510(k) Number (if known): __ K023234_
Device Name: Endoscopic Plication System
Indications for Use: The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to phamacological therapy.
(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_
(Optional Format 1-2-96)
iriam C Provost
510(k) Nun
\\DC - 71403/600 · 0809482.01
3
023234 (P.1uf2)
510 (k) SUMMARY
APR 1 7 2003
1. SUBMITTER:
NDO Surgical, Inc. 125 High St Mansfield, MA 02048
Contact: Eric Bannon, Vice President of Clinical, Regulatory and Quality Assurance Date Prepared: September 25, 2002
2. DEVICE:
Trade Name: NDO Surgical Endoscopic Plication System Classification Name: Endoscope and Accessories The Product Code: KOG
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the NDO Surgical Endoscopic Plication System was the Bard EndoCinch Suturing System.
4. DEVICE DESCRIPTION:
The Endoscopic Plication System consists of an instrument, retractor, overtube and implant.
The instrument is passed transorally to create a plication in close proximity to the gastroesophageal junction.
The implant is designed to help pass and secure the suture.
The retractor is designed to secure and retract the tissue during the placement of the implant. It is placed down a working channel of the instrument prior to the procedure.
The overtube is designed to protect the esophagus during the procedure.
4
5. INTENDED USE:
The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
6. COMPARISON OF CHARACTERISTICS:
- The devices have the same intended and indication for use, have very similar 마 technical characteristics and principles of operation.
- Bench and animal testing demonstrate that any minor technological . differences do not raise any new questions of safety and effectiveness.
- The clinical comparison shows that the NDO Endoscopic Plication System to I be at least as safe and effective as the Bard EndoCinch
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- . Mechanical evaluation
- In-Vivo safety study ●
- . In-Vitro evaluation
- Clinical evaluation .