(43 days)
Not Found
No
The device description focuses on mechanical components and their function in creating a plication. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended for the "treatment of the symptoms of chronic gastroesophageal reflux disease (GERD)," directly indicating a therapeutic purpose.
No
The device is described as a treatment device, delivering an implant to create a plication for GERD, and not for diagnostic purposes.
No
The device description clearly outlines multiple hardware components (Endoscopic Plication Instrument, Retractor, Implant Cartridge, implant made of titanium, polypropylene suture, ePTFE pledgets) 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 performed in vivo (within the patient's body).
- Device Description: The device is a surgical system designed to deliver an implant and physically modify tissue. This is characteristic of a surgical or therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, the NDO EPS System is a therapeutic medical 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 pharmacological therapy.
Product codes (comma separated list FDA assigned to the subject device)
ODE
Device Description
The NDO Surgical Endoscopic Plication System is a device intended to deliver an implant in the stomach near the Gastroesophageal Junction that creates a full thickness plication for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three components: the Endoscopic Plication Instrument, the Retractor and the Implant Cartridge. The Implant Cartridge and retractor are loaded onto the instrument; this is then passed transorally into the stomach to create the plication. The instrument's shaft, which comes into contact with the patient, is made of polyvinyl chloride coated with parylene. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The implant is comprised of two titanium tees, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the system has been introduced into the stomach, the retractor is engaged into the gastric mucosa and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating the full thickness, serosa-to-serosa plication.
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)
Bench top, In-Vivo simulated use and ex-vivo performance testing were completed in support of the substantial equivalence determination. The testing demonstrates substantially equivalent performance between the two devices
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.
Not Found
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, formed by three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 2 7 2015
NDO Surgical, Inc. Mr. Eric Bannon Vice President of Regulatory, Clinical and Quality Assurance 125 High Street, Suite 7 Mansfield, MA 02048
Re: K032820
Trade/Device Name: Endoscopic Plication System, Model # 160-00760 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODE Dated (Date on orig SE ltr): October 13, 2003 Received (Date on orig SE ltr): October 14, 2003
Dear Mr. Bannon,
This letter corrects our substantially equivalent letter of October 23, 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
ATTACHMENT 1
510(k) Number (if known):_K032820
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 pharmacological 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 _________________________________________________________________________________________________________________________________________________________
David R. Ingram
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032820
3
OCT 2 3 2003
K03 2820
page 1 of 2
Attachment 6
510(K) SUMMARY
1. SUBMITTER:
NDO Surgical, Inc. 125 High St. Mansfield, MA 02048 Telephone: 508-337-8881 Fax: 508-337-8882
Contact: Eric Bannon, Vice President, Regulatory, Clinical, QA Date Prepared: September 8, 2003
2. DEVICE:
Trade Name: NDO Surgical Endoscopic Plication System Class: II Classification Name: Endoscope and accessories
3. PREDICATE DEVICE:
NDO Surgical Endoscopic Plication System (K023234)
4. DEVICE DESCRIPTION:
The NDO Surgical Endoscopic Plication System is a device intended to deliver an implant in the stomach near the Gastroesophageal Junction that creates a full thickness plication for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three components: the Endoscopic Plication Instrument, the Retractor and the Implant Cartridge. The Implant Cartridge and retractor are loaded onto the instrument; this is then passed transorally into the stomach to create the plication. The instrument's shaft, which comes into contact with the patient, is made of polyvinyl chloride coated with parylene. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The implant is comprised of two titanium tees, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the system has been introduced into the stomach, the retractor is engaged into the gastric mucosa and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating the full thickness, serosa-to-serosa plication.
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 proposed Endoscopic Plication System, is an updated design of the predicate device, it is therefore similar in intended use and function. The design changes made are to further improve patient safety and to allow increased endoscopic visualization of the instrument during the procedure. Additionally, changes were made to the instrument to enable the instrument to be cleaned and processed in a similar manner to that of a standard endoscope.
The indications being requested for the proposed EPS are already cleared for the predicate EPS.
7. PERFORMANCE DATA:
Bench top, In-Vivo simulated use and ex-vivo performance testing were completed in support of the substantial equivalence determination.
The testing demonstrates substantially equivalent performance between the two devices