(115 days)
The provided text does not contain any predicate device K/DEN numbers. The "Predicate Device(s)" section explicitly states "Not Found".
Not Found
No
The description focuses on the mechanical function of a reusable surgical instrument for aspiration, irrigation, and tube positioning. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
The device is used for delivering and removing fluids and positioning tubes during surgery; it does not directly treat or prevent a disease or condition.
No
The device is described as an irrigation/aspiration instrument used to deliver and remove fluids, and position tubes during surgery. Its function is interventional, not diagnostic, as it does not gather information for diagnosis.
No
The device description clearly states it is a reusable stainless steel instrument with a positioning guide, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use by surgeons during endoscopic abdominal and thoracic surgical procedures to deliver and remove irrigation fluid and to localize and remove various tubes. This is a surgical instrument used in vivo (within the body) during a procedure.
- Device Description: The description details a reusable stainless steel instrument for surgical use. It describes its physical characteristics and function during surgery.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device is a surgical instrument used directly on the patient during a procedure, not for analyzing samples in a lab setting.
N/A
Intended Use / Indications for Use
The ESSeX Aspiration/Irrigation and Positioning Guide is intended for use by surgeons during endoscopic abdominal and thoracic surgical procedures to deliver and remove irrigation fluid to and from the operative site, localizing and removal of irrigation, feeding, drainage, and chest tubes.
Product codes
GCJ
Device Description
The ESSeX Aspiration/Irrigation Instrument with Positioning Guide is a reusable stainless steel irrigation/aspiration instrument with a positioning guide. The instrument is designed to for use during endoscopic surgical procedures.
ESSeX Aspiration/Irrigation Instrument with Positioning Guide is The manufactured from surgical grade stainless steel. The instrument has an overall operating length of 35.6cm and an outer diameter of 7.5 mm. The instrument functions as a standard suction/irrigator and provides for the localization and removal of a variety of irrigation, feeding, drainage, and chest tubes. The positioning quide component of the instrument is attached in such a manner that allows for the delivery or capture of irrigation or drainage tubes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal and thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons, endoscopic abdominal and thoracic surgical procedures
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)
All necessary testing will be performed on the ESSeX Aspiration/Irrigation Instrument with Positioning Guide and packaging to ensure that the product is substantially equivalent to the predicate devices and to ensure the safety and effectiveness of the device.
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
APPENDIX A. 510(k) SUMMARY FEB 2 0 2003
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Name, Address, Phone and Fax number of the Applicant A.
Guidant Corporation Cardiac Surgery 3200 Lakeside Drive Santa Clara, CA 95054
Telephone: Fax: (408) 845-1855
- B. Contact Person Debbie Cogan Regulatory Affairs Associate
- C. Date Prepared
January 24, 2003
D. Device Name
Trade Name: ESSeX Aspiration/Irrigation Instrument with Positioning Guide Classification Name: General & Plastic Surgery
ய் Device Description
The ESSeX Aspiration/Irrigation Instrument with Positioning Guide is a reusable stainless steel irrigation/aspiration instrument with a positioning guide. The instrument is designed to for use during endoscopic surgical procedures.
ESSeX Aspiration/Irrigation Instrument with Positioning Guide is The manufactured from surgical grade stainless steel. The instrument has an overall operating length of 35.6cm and an outer diameter of 7.5 mm. The instrument functions as a standard suction/irrigator and provides for the localization and removal of a variety of irrigation, feeding, drainage, and chest
1
tubes. The positioning quide component of the instrument is attached in such a manner that allows for the delivery or capture of irrigation or drainage tubes.
F. Intended Use
The ESSeX Aspiration/Irrigation and Positioning Guide is intended for use by surgeons during endoscopic abdominal and thoracic surgical procedures to deliver and remove irrigation fluid to and from the operative site, localizing and removal of irrigation, feeding, drainage, and chest tubes.
G. Substantial Equivalence
Guidant Cardiac Surgery proposes that the ESSeX Aspiration/Irrigation Instrument with Positioning Guide is substantially equivalent to a instrument (21 CFR 876.1500). The ESSeX Suction/Irrigator Aspiration/Irrigation Instrument with Positioning Guide is substantially equivalent to the Karl Storz Suction/Irrigation Instrument. The comparison presented in the substantial equivalency table demonstrates that the subject device is substantially equivalent to the predicate device with regard to intended use, indications, device characteristics, and method of use, labeling, materials, and safety features.
Device Testing Results and Conclusion H.
All necessary testing will be performed on the ESSeX Aspiration/Irrigation Instrument with Positioning Guide and packaging to ensure that the product is substantially equivalent to the predicate devices and to ensure the safety and effectiveness of the device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
FEB 2 0 2003
Food and Drug Administration 9200 Corporate: Boulevard Rockville MD 20850
Guidant Corporation c/o Ms. Michelle Weidman Office Assistant Coordinator Kema Medical 4377 County Line Road Chalfont, Pennsylvania 18914
Re: K023630
Trade/Device Name: Essex Aspiration/Irrigation Instrument with Positioning Guide Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 31, 2003 Received: February 3, 2003
Dear Ms. Weidman:
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.
3
Page 2 - Ms. Michelle Weidman
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 Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX F. INDICATION FOR USE STATEMENT
510(k) Number (if known): K_
Device Name:
ESSeX Aspiration/Irrigation Instrument with Positioning Guide
Indications For Use:
The ESSeX Aspiration/Irrigation and Positioning Guide is intended for use by surgeons during endoscopic abdominal and thoracic surgical procedures to deliver and remove irrigation fluid to and from the operative site, localizing and removal of irrigation, feeding, drainage, and chest tubes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
ូរ
OR (Per 21 CFR 801.109) Over-The-Counter Use_
(Optional Format 1-2-9
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_K023630
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1/24/2003