(17 days)
Not Found
No
The device description and intended use describe mechanical laparoscopic instruments, and there is no mention of AI, ML, or image processing.
No
The device is described as surgical instruments (scissors, grasping forceps, dissectors, and needle holders) used for manipulating tissue during laparoscopic procedures. While therapeutic procedures involve treating a condition, these instruments are tools used during such procedures rather than being therapeutic devices themselves that directly provide a therapeutic effect to the patient.
No
The device is described as an accessory for manipulating tissue in laparoscopic diagnostic and surgical procedures, indicating it is an surgical tool rather than a device for diagnosis.
No
The device description clearly states it is composed of a reusable handle, shaft assembly, and removable tip assembly, 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 used for "manipulating tissue (grasping, cutting, coagulating, dissecting and suturing)" during laparoscopic procedures. This is a surgical function performed on the patient's body.
- Device Description: The description details instruments for manipulating soft tissue structures, which aligns with surgical tools.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of these samples.
Therefore, this device falls under the category of surgical instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Allegiance Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders are used as accessories in general laparoscopic diagnostic and surgical procedures for manipulating tissue (grasping, cutting, dissecting coagulating and suturing).
Product codes
GCJ
Device Description
The Allegiance Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders are composed of a reusable handle and shaft assembly and a removable tip assembly. These instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures.
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
All materials used in the composition of the Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders were subjected to performance and physical tests to evaluate the safety, effectiveness and reliability of the device. All test results were acceptable.
Key Metrics
Not Found
Predicate Device(s)
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/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a plus sign made up of small dots. The word is in black and the background is white.
Allegiance Healthcare Corporation
1500 Waukegan Road McGaw Park, IL 60085
847.473.1500 FAX: 847.785.2461
JUN 25 1999
K 991928
SUMMARY OF SAFETY AND EFFECTIVENESS Attachment G
| Manufacturer: | Allegiance Healthcare Corporation
V. Mueller Business Unit
1430 Waukegan Road
McGaw Park, IL 60085 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact | Patricia Sharpe-Gregg
1500 Waukegan Road
McGaw Park, Illinois 60085 |
| Telephone: | (847) 578-3636 |
| Date Summary Prepared: | June 1, 1999 |
| Product Trade Name: | Modular Endoscopy Laparoscopic Scissors,
Grasping Forceps, Dissectors and Needle Holders |
| Common Name: | Laparoscopic Scissors, Grasping Forceps,
Dissectors & Needle Holders |
| Classification: | Gynecologic Laparoscope and Accessories |
| Predicate Device:
(K931340) | "Resposable" Grasping Forceps/ Scissors/
Needle Holder/ Dissectors |
| Description: | The Allegiance Modular Endoscopy
Laparoscopic Scissors, Grasping Forceps,
Dissectors and Needle Holders are composed
of a reusable handle and shaft assembly and a
removable tip assembly. These instruments
are designed and manufactured specifically for
the purpose of manipulating soft tissue
structures. |
1
| Intended Use: | The Allegiance Modular Endoscopy
Laparoscopic Scissors, Grasping Forceps,
Dissectors and Needle Holders are used as
accessories in general laparoscopic diagnostic
and surgical procedures for manipulating
tissue (grasping, cutting, dissecting
coagulating and suturing). |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Modular Endoscopy Laparoscopic
Scissors, Grasping Forceps, Dissectors and
Needle Holders are substantially equivalent to
the Allegiance the "Resposable" Grasping
Forceps/ Scissors/ Needle Holder/ Dissectors,
in that:
• Intended use is the same
• Performance attributes are the same
• Materials and basic design are the same |
| Summary of Testing: | All materials used in the composition of the
Modular Endoscopy Laparoscopic Scissors,
Grasping Forceps, Dissectors and Needle
Holders were subjected to performance and
physical tests to evaluate the safety,
effectiveness and reliability of the device. All
test results were acceptable. |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with three lines representing arms or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1999
Ms. Patricia Sharpe-Gregg Manager, Regulatory Affairs Allegiance Healthcare Corp. 1500 Waukegan Road William Merz Building McGaw Park, Illinois 60085
K991928 Re:
Trade Name: Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors, and Needle Holders
Regulatory Class: II Product Code: GCJ Dated: June 7, 1999 Received: June 8, 1999
Dear Ms. Sharpe-Gregg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Patricia Sharpe-Gregg
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA 847-578-3636 FAX: 847-785-2461
Special 510(k) Device Modification: Laparoscopic Grasping Forceps, Scissors, Needle Holders & Dissectors V. Mueller Business Unit Page 1 of 1
kg91928 510(k) Number (if known): Unknown Laparoscopic Grasping Forceps, Scissors, Needle Device Name: Holders and Dissectors Used as accessories in general laparoscopic Indications For Use: diagnostic and surgical procedures for manipulating tissue (grasping, cutting, coagulating, dissecting and suturing).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| or | Over-The Counter Use |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K991228 |
|---|---|
| --------------- | --------- |