(542 days)
Not Found
No
The device description and performance studies focus on the reprocessing of a physical surgical tool (trocar) and do not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device facilitates surgical procedures by providing a port of entry for instruments but does not directly treat a disease or condition.
No
Explanation: The device, a trocar, is used to create a port of entry for surgical instruments during minimally invasive procedures. It facilitates the insertion of other tools, but does not itself provide diagnostic information about a patient's condition.
No
The device description clearly describes a physical medical device (trocars) that are reprocessed, 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 "establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures." This describes a surgical tool used directly on a patient during a procedure.
- Device Description: The description details a physical device inserted into the body to create a pathway for other surgical tools. It mentions features like a luer stopcock for insufflation, which are related to surgical procedures, not diagnostic testing of samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical instrument used for access during a procedure.
N/A
Intended Use / Indications for Use
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Product codes
NLM
Device Description
Trocars are devices inserted into a patient in order to maintain a clear pathway to facilitate the insertion of various surgical tools. Trocars are designed in both bladed and non-bladed configurations, however this submission is for non-bladed B5LTs. Non-bladed trocars require an incision be made before insertion into the patient's cavity. Trocars have a luer stopcock port for insufflation and desufflation of the patient's cavity. NES Reprocessed Endoscopic Trocars are sent from a user facility to be cleaned, sterilized and repackaged by NES. NES Reprocessed Endoscopic Trocars have the same intended use and performance characteristics equivalent to Endoscopic Trocars provided by Original Equipment Manufacturers (OEM).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
NES Reprocessed Endoscopic Trocars operate as originally intended and are safe, effective and sterile as demonstrated by cleaning, packaging, performance, sterilization and biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K011538, K011257, K990028, K971738, K922608
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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| Section 2-1 | 510(k) Summary | ||
|---|---|---|---|
| Submitter | Northeast Scientific, Inc. | ||
| 29 S. Commons Rd. | |||
| Waterbury, CT 06704 | SEP - 7 2007 | ||
| Contact | Craig Allmendinger | ||
| President & CEO | |||
| Phone: 203-756-2111 | |||
| Fax: 203-757-5532 | |||
| Email: Allmendinger@sbcglobal.net | |||
| Date | August 31st, 2007 | ||
| Device | Trade Name: NES Reprocessed Endoscopic Trocar | ||
| Common Name: Non-Bladed Trocar | |||
| Classification Name: Endoscope and accessories | |||
| Product Code: NLM | |||
| Device Class: Class II | |||
| OEM Models: Ethicon XCEL B5LT | |||
| Predicate Devices | 510(k) # | Trade Name | |
| K011538: | Endopath® Non-Bladed Solid Obturator Trocar | ||
| K011257: | Endopath® Non-Bladed Obturator Trocar System | ||
| (5mm) | |||
| K990028: | Endopath® Optiview® Optical Surgical Obturator | ||
| and Sleeve | |||
| K971738: | Ethicon Endopath® Resposable Trocar System | ||
| K922608: | Endopath® EP Disposable Surgical Trocar | ||
| Indications for Use | NES Reprocessed Endoscopic Trocars are indicated for use to | ||
| establish a port of entry for endoscopic instruments in patients | |||
| requiring minimally invasive surgical procedures. | |||
| Contraindications | NES Reprocessed Endoscopic Trocars are not intended to be used | ||
| on patients undergoing open surgical procedure and for whom | |||
| endoscopic procedure has been contraindicated. | |||
| Device Description | Trocars are devices inserted into a patient in order to maintain a | ||
| clear pathway to facilitate the insertion of various surgical tools. | |||
| Trocars are designed in both bladed and non-bladed | |||
| configurations, however this submission is for non-bladed B5LTs. | |||
| Non-bladed trocars require an incision be made before insertion | |||
| into the patient's cavity. Trocars have a luer stopcock port for | |||
| insufflation and desufflation of the patient's cavity. NES | |||
| K060676 | Page 2 of 2 | ||
| Reprocessed Endoscopic Trocars are sent from a user facility to be | |||
| cleaned, sterilized and repackaged by NES. NES Reprocessed | |||
| Endoscopic Trocars have the same intended use and performance | |||
| characteristics equivalent to Endoscopic Trocars provided by | |||
| Original Equipment Manufacturers (OEM). | |||
| Technological | |||
| Characteristics | NES Reprocessed Endoscopic Trocars have identical | ||
| design, materials, characteristics and intended use as the | |||
| OEM Trocars. | |||
| Test Data | NES Reprocessed Endoscopic Trocars operate as originally | ||
| intended and are safe, effective and sterile as demonstrated by | |||
| cleaning, packaging, performance, sterilization and | |||
| biocompatibility testing. | |||
| Conclusion | Based on the information provided, NEScientific, Inc. concludes | ||
| that NES Reprocessed Endoscopic Trocars are safe, effective, | |||
| perform as intended and are substantially equivalent to the | |||
| predicate devices identified herein. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2007
Northeast Scientific, Inc. % Mr. Craig Allmendinger President & CEO 29 South Commons Road Waterbury, Connecticut 06704
Re: K060676
Trade/Device Name: NES Reprocessed Endoscopic Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: August 8, 2007 Received: August 9, 2007
Dear Mr. Allmendinger:
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.
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.
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Page 2 - Mr. Craig Allmendinger
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 premated 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,
for
Mark N. Melkerson Dep. Dir.
9/16/05
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K06.676
Pape 0/7
Indications for Use
510(k) Number (if known): K060676
Device Name: NES Reprocessed Endoscopic Trocar
Indications For Use:
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number C060676
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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K060676 List of Reprocessed Device(s):
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| Description | Model Number | Size (ID/Length) |
|---|---|---|
| Ethicon XCEL Bladeless Endoscopic | ||
| Trocar | B5LT | 5 mm diameter x 100 mm |