(70 days)
Not Found
No
The summary describes a reprocessed electrosurgical instrument and its intended use. There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies focus on the instrument's ability to perform its intended function, not on any analytical or interpretive capabilities.
Yes
The device is used to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue, which are all therapeutic actions in surgical procedures.
No
This device is described as an electrosurgical instrument used to manipulate, cut, dissect, cauterize, or coagulate internal soft tissue during minimally invasive surgical procedures, not to diagnose a condition.
No
The device description clearly outlines a physical, electrosurgical instrument with a handpiece, shaft, and end effector jaws, designed for insertion into the body and delivery of electrical current. This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) outside of the body to provide information about a person's health.
- Device Function: The description clearly states that this device is a surgical instrument used within the body during minimally invasive procedures to manipulate, cut, dissect, cauterize, or coagulate tissue. It directly interacts with internal soft tissue.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze samples or provide diagnostic information based on laboratory testing.
The device described is a surgical instrument used for therapeutic purposes during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Reprocessed unipolar laparoscopic/endoscopic instruments, including scissors, dissectors, and graspers are intended for use in minimally invasive surgical procedures.
Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, including scissors, dissectors, and graspers, are to be used for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.
Product codes
GEI
Device Description
Unipolar laparoscopic/endoscopic instruments are electrosurgical instruments consisting of a rigid plastic handpiece with loop handles connected to the distal end effector jaw by an elongated, narrow- diameter insulated barrel or shaft. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The jaws are operated by the handpiece loop handles and may be shaped as scissors, dissectors or graspers. The jaws of some models may be rotated by manipulating controls on the handpiece.
The blades or jaws of unipolar laparoscopic/endoscopic instruments can deliver a cauterizing current that enters the instrument through the unipolar cautery connector on the handpiece, runs down the insulated shaft and through the tissue in the blades or jaws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal soft tissue
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)
Performance data demonstrates that Reprocessed Unipolar Laparoscopic/Endoscopic Instruments perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
OCT 22 2001
PART B: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter:
KO 12625 Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Contact:
Don Selvey Vice President, Regulatory Affairs and Quality Assurance (480) 763-5300
Date of preparation:
August 10, 2001
Name of device:
Trade/Proprietary Name: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments
Common or Usual Name: Unipolar Laparoscopic/Endoscopic Instruments
Classification Name: Endoscope and Accessories and/or Electrosurgical Cutting and Coagulation Device and Accessories
Reprocessed devices:
| Manufacturer | Description | Model |
|---|---|---|
| Ethicon | Endopath ® Endo Metzenbaum Scissor | BMS10 |
| Ethicon | Endopath ® Curved Scissor | DCS12 |
| Ethicon | Endopath ® Hook Scissor | DHS14 |
| Ethicon | Endopath ® Micro-Scissor | DMS15 |
| Ethicon | Endopath ® Curved Scissor | 5DCS |
| Ethicon | Endopath ® Curved Scissor, Short | SCS12 |
| Ethicon | Endopath ® Straight Grasper | DSG22 |
| Ethicon | Endopath ® Modified Allis Grasper | DSG23 |
| Ethicon | Endopath ® Ratchet Grasper | 5DSG |
| Ethicon | Endopath ® Claw Extractor | DEX41 |
| Ethicon | Endopath ® Curved Dissector | DCD32 |
| Ethicon | Endopath ® Straight Dissector | DSD33 |
| Ethicon | Endopath ® Curved Dissector | 5DCD |
| Ethicon | Endopath ® Curved Dissector | SCD32 |
Predicate device(s):
| K# | Device Description | Procode |
|---|---|---|
| K984240 | Ethicon Endopath ® Endoscopic Instrument | GEI |
| Ethicon Endopath ® Endoscopic | ||
| K934784 | Electrosurgical Forceps | GEI |
| Ethicon Endopath ® Endoscopic Surgical | ||
| K930933 | Instruments | GCJ |
Alliance Medical Corporation Reprocessed Laparoscopic/Endoscopic Instruments Traditional 510(k)
9
1
| Device
description: | Unipolar laparoscopic/endoscopic instruments are electrosurgical
instruments consisting of a rigid plastic handpiece with loop handles
connected to the distal end effector jaw by an elongated, narrow-
diameter insulated barrel or shaft. The devices are designed to be
inserted through an appropriately sized trocar sleeve or cannula. The
jaws are operated by the handpiece loop handles and may be shaped
as scissors, dissectors or graspers. The jaws of some models may be
rotated by manipulating controls on the handpiece. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The blades or jaws of unipolar laparoscopic/endoscopic instruments can
deliver a cauterizing current that enters the instrument through the
unipolar cautery connector on the handpiece, runs down the insulated
shaft and through the tissue in the blades or jaws. |
| Intended use: | Reprocessed unipolar laparoscopic/endoscopic instruments, including
scissors, dissectors, and graspers are intended for use in minimally
invasive surgical procedures. |
| Indications
statement: | Reprocessed unipolar laparoscopic/endoscopic instruments, including
scissors, dissectors, and graspers, are to be used for patients requiring
minimally invasive surgical procedures to manipulate and manage
internal soft tissue by grasping, cutting, dissecting, cauterizing, or
coagulating tissue. |
| Technological
characteristics: | The intended use and technological features of the reprocessed devices do
not differ from the legally marketed predicate device(s). Both the
reprocessed device(s) and the predicate device(s) have the same materials
and product design. The technological characteristics of the reprocessed
unipolar laparoscopic/endoscopic scissors, dissectors, and graspers are the
same as those of the legally marketed predicate devices. |
| | Alliance Medical Corporation's reprocessing of unipolar
laparoscopic/endoscopic instruments includes removal of adherent visible
soil and decontamination. All unipolar laparoscopic/endoscopic instruments
are tested for electrical continuity. Unipolar laparoscopic/endoscopic
scissors are tested for cutting function. Graspers and dissectors are tested
for the ability of the jaws to grasp appropriately. |
| Performance
data: | Performance data demonstrates that Reprocessed Unipolar
Laparoscopic/Endoscopic Instruments perform as originally intended. |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act, 21
CFR Part 807 and based on the information provided in this
premarket notification, Alliance Medical Corporation concludes that
the modified device (Reprocessed Unipolar Laparoscopic/Endoscopic
Instruments) is safe, effective and substantially equivalent to the
predicate devices as described herein. |
.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a triple helix design representing the interconnectedness of health, science, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation.
OCT 22 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Don Selvey Vice President, Regulatory Affairs and Ouality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K012625
Trade/Device Name: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 10, 2001 Received: August 13, 2001
Dear Mr. Selvey:
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 - Mr. Don Selvey
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and my Journe FDA finding of substantial equivalence of your device to a legally premated notification " 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 Oixision 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,
Susan Walker, us
Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive letter, possibly an 'h' or a stylized 'l', with a small flourish or stroke extending to the right. The character is drawn with thick lines, suggesting it was written with a marker or pen with a broad tip.
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
4
II. Indications for Use Statement
K012625 510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed Unipolar Laparoscopic/Endoscopic Instruments
Indications for Use: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, including scissors, dissectors, and graspers, are to be used for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.
| Manufacturer | Description | Model |
|---|---|---|
| Ethicon | Endopath® Endo Metzenbaum Scissor | BMS10 |
| Ethicon | Endopath® Curved Scissor | DCS12 |
| Ethicon | Endopath® Hook Scissor | DHS14 |
| Ethicon | Endopath® Micro-Scissor | DMS15 |
| Ethicon | Endopath® Curved Scissor | 5DCS |
| Ethicon | Endopath® Curved Scissor, Short | SCS12 |
| Ethicon | Endopath® Straight Grasper | DSG22 |
| Ethicon | Endopath® Modified Allis Grasper | DSG23 |
| Ethicon | Endopath® Ratchet Grasper | 5DSG |
| Ethicon | Endopath® Claw Extractor | DEX41 |
| Ethicon | Endopath® Curved Dissector | DCD32 |
| Ethicon | Endopath® Straight Dissector | DSD33 |
| Ethicon | Endopath® Curved Dissector | 5DCD |
| Ethicon | Endopath® Curved Dissector | SCD32 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
(Division Sign-Off)
General, Restorative
510(k) Number K012625
CONFIDENTIAL
Alliance Medical Corporation Reprocessed Laparoscopic/Endoscopic Instruments Traditional 510(k)
or