(86 days)
Not Found
Not Found
No
The summary describes reprocessed surgical instruments and does not mention any AI/ML capabilities or related concepts like image processing, training data, or performance metrics typically associated with AI/ML devices.
No
The device is described as surgical instruments used to manipulate and manage internal soft tissue during minimally invasive procedures, which are tools used by healthcare professionals for a procedure, not a device that directly or indirectly treats or prevents disease.
No
The device description indicates that these instruments are used for manipulation, cutting, dissection, cauterization, or coagulation of tissue during surgical procedures. These are interventional actions, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description explicitly states "Reprocessed Unipolar Laparoscopic/Endoscopic Instruments," which are physical hardware devices used in surgery. The summary does not mention any software component as the primary or sole function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used during surgical procedures to manipulate and manage internal soft tissue. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo.
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health.
- Device Description: The description of the instruments (scissors, dissectors, graspers) aligns with surgical tools used directly on the patient, not for analyzing samples.
The information provided strongly indicates this is a surgical instrument used in vivo, not an IVD used in vitro.
N/A
Intended Use / 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.
Product codes
NUJ
Device Description
Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, including scissors, dissectors, and graspers.
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)
Not Found
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
§ 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
Image /page/0/Picture/1 description: The image shows the text "Public Health Service" in bold, black font. The text is horizontally oriented and appears to be a title or heading. The background is plain white, providing a clear contrast for the text.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The words "HUMAN SERVICES USA" are arranged in an arc at the top of the logo, and the words "DEPARTMENT OF" are arranged in an arc at the bottom.
AUG - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Renken Regulatory Affairs Specialist Alliance Medical Corporation 10232 South 51" Street Phoenix, Arizona 85044
KO12603 Supplemental Validation Submission Re: Trade/Device Name: Alliance Medical Corporation Reprocessed Unipolar Laparoscopic/Endoscopic Instruments (See Enclosed List) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NUJ Dated: March 14,2005 Received: March 15,2005
Dear Ms. Renken:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on November 7.2001. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.
1
Page 2 - Ms. Elizabeth Renken
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Styfe Rlwd
Mark N. Melkerson Acting Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KO12603
ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
· ·· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
・・
| Manufacturer | Description | Model |
|---|---|---|
| US Surgical | Autosuture ® Endo Mini-shears | 174301 |
| US Surgical | Autosuture ® Endo Shear Short | 174501 |
| US Surgical | Autosuture® Endo Shear Long | 174601 |
| US Surgical | Autosuture® Endo Mini-shears short | 174503 |
| US Surgical | Autosuture® Endo Shears | 176643 |
| US Surgical | Autosuture® Endo Dissect | 176645 |
| US Surgical | Autosuture® Endo Dissect, Short | 174505 |
Stypt Rurla
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number___KO42602_
3
NOV 0 7 2001 II. Indications for Use Statement
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 |
|---|---|---|
| US Surgical | Autosuture ® Endo Mini-shears | 174301 |
| US Surgical | Autosuture® Endo Shear Short | 174501 |
| US Surgical | (Autosuture® Endo Shear Long | 174601 |
| US Surgical | Autosuture® Endo Mini-shears short | 174503 |
| US Surgical | Autosuture® Endo Shears | 176643 |
| US Surgical | Autosuture® Endo Dissect | 176645 |
| US Surgical | Autosuture Endo Dissect. Short | 174505 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
t Prescription Use (per 21 CFR801.109)
or
Over-the-counter Use _
Susan Walker, MD
(Division Sign-Off) Division of General, Restorative and Neurological Devices
CONFIDENTIAL
510(k) Number K01240
Alliance Medical Corporation
Reprocessed Laparoscopic/Endoscopic Instruments
Traditional 510(k)
12