(51 days)
No
The description focuses on the mechanical function of the device (grasping, cutting) and does not mention any computational or data-driven features. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device description indicates that it is a surgical instrument used to facilitate grasping, mobilization, dissections, and transection of tissue, which are actions performed during a therapeutic procedure but the device itself does not provide a therapeutic effect.
No
The device, endoscopic scissors and graspers, is described as surgical instruments used for grasping, mobilization, dissections, and transection of tissue during minimally invasive procedures. Its function is to perform actions on tissue, not to diagnose conditions or diseases.
No
The device description clearly states it is a hand-manipulated physical instrument with shafts and grasping/cutting capabilities, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used during surgical procedures to manipulate tissue (grasping, mobilization, dissection, transection). This is a direct surgical intervention, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description confirms it's a hand-manipulated surgical instrument used during minimally invasive procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used to perform actions on the body during a procedure.
N/A
Intended Use / Indications for Use
Endoscopic scissors and graspers are instruments that have a 5 to 10 mm diameter insulated shaft designed for use through surgical trocars. Endoscopic scissors and graspers, in conjunction with trocars, are used in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissections and transection of tissue.
Product codes
79GCJ, 79GEI, HET, MDM
Device Description
AMI intends to market Endoscopic Scissors and Graspers that have been reprocessed. Reprocessing Endoscopic Scissors and Graspers is performed by AMI to AMI protocol Number 40011. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals.
Endoscopic Scissors and Graspers are sold new by the original manufacturers to the hospital. The hospital uses the Endoscopic Scissors and Graspers, collects them and ships them to AMI for reprocessing. Endoscopic Scissors and Graspers are reprocessed by AMI as described in our reprocessing protocol Control Document Number 400011, and returned to the hospital to be reused as a single-use device again.
Endoscopic Scissors and Graspers that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the device is not reprocessed at all) or anytime during subsequent reprocessings.
Endoscopic Surgical Scissors and Graspers are hand-manipulated devices, with and without electrocautery capability; and with and without rotation capability. They are designed for use during minimally invasive surgical procedures and are equipped with elongated shafts to fit through the surgical trocar cannula.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/1 description: The image shows the text "Adven Medical, Inc." in a serif font. The text is black and the background is white. A black line is underneath the text.
1001 Slaton Hwv. Lubbock, Texas 79404
Tel: (806) 745-7718 Fax: (806) 745-0223 OCT 0 9 2002
510(k) SUMMARY
Adven Medical, Incorporated Reference: Section 510(k) Notification Reprocessed Used Disposable Endoscopic Scissors and Graspers
Classification name:
Common/Usual Name: Proprietary Name:
79GCJ. Manual Laparoscopic Surgical Instruments 79GEI, Endoscopic Electrosurgical Instruments Laparoscopic/Endoscopic Surgical Instruments Reprocessed Used Disposable Endoscopic Scissors and Graspers
Establishment Registration Number: 1649663
AMI intends to market Endoscopic Scissors and Graspers that have been reprocessed. Reprocessing Endoscopic Scissors and Graspers is performed by AMI to AMI protocol Number 40011. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals.
Endoscopic Scissors and Graspers are sold new by the original manufacturers to the hospital. The hospital uses the Endoscopic Scissors and Graspers, collects them and ships them to AMI for reprocessing. Endoscopic Scissors and Graspers are reprocessed by AMI as described in our reprocessing protocol Control Document Number 400011, and returned to the hospital to be reused as a single-use device again.
Endoscopic Scissors and Graspers that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the device is not reprocessed at all) or anytime during subsequent reprocessings.
Endoscopic Surgical Scissors and Graspers are hand-manipulated devices, with and without electrocautery capability; and with and without rotation capability. They are designed for use during minimally invasive surgical procedures and are equipped with elongated shafts to fit through the surgical trocar cannula.
Adven Medical, Inc., Reprocessed Endoscopic Scissors and Graspers are substantially equivalent to Ethicon Endo-surgery Disposable Endoscopic Scissors and Graspers, currently marketed new by Ethicon under 510(k) Number K960933.
000008
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with three heads in profile, facing right. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the top and sides of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Device Services c/o Mr. Mark W. Aldana President Adven Medical, Inc. 1001 Slaton Highway Lubbock, Texas 79404
Re: K022748
Trade/Device Name: Reprocessed Disposable Endoscopic Scissors and Graspers Regulation Number: 884.1720, 878.4800
Regulation Name: Gynecological laparoscope and accessories, Manual surgical instruments for general use.
Regulatory Class: II Product Code: HET, MDM Dated: August 9, 2002 Received: august 19, 2002
Dear Mr. Aldana:
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.
2
Page 2 – Mr. Mark W. Aldana
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
Stupt Rurder
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
3
510(k) Number: K022748
Reprocessed Used, Disposable Endoscopic Scissors and Graspers Device Name:
Indications For Use:
Endoscopic scissors and graspers are instruments that have a 5 to 10 mm diameter insulated shaft designed for use through surgical trocars. Endoscopic scissors and graspers, in conjunction with trocars, are used in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissections and transection of tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stupt Rhode
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number___KO2274 8
Prescription Use _ (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)