(111 days)
Not Found
No
The description focuses on the mechanical and electrical functions of the biopsy forceps and reprocessing procedures, with no mention of AI or ML.
No.
The device is used for removal of tissue and polyps, but it is not intended to treat or cure a disease or condition; it is a surgical tool.
No
Explanation: The device description clearly states its purpose is for electrocautery and removal of polyps and tissue, not for diagnosis. While tissue collection might be an initial step in a diagnostic process, the device itself performs a therapeutic or interventional function (tissue removal/electrocautery), not a diagnostic one.
No
The device description clearly outlines physical components (flexible sheaths, grasping cups, proximal handle) and a reprocessing process involving cleaning, inspection, testing, repackaging, and sterilization of these physical components. This indicates a hardware-based medical device, not a software-only one.
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 these electric biopsy forceps are used within the gastrointestinal tract to remove polyps and/or tissue. The tissue is removed from the body, but the device's primary function is the removal and electrocautery within the body, not the analysis of a specimen outside the body.
- Intended Use: The intended use is for "electrocautery and removal of polyps and/or tissue within the gastrointestinal tract." This is an interventional procedure performed inside the body.
- Device Description: The description focuses on the mechanical and electrical aspects of the device for use during an endoscopic procedure.
While the device collects tissue samples, the device itself is not performing the diagnostic test on that sample. The diagnostic testing would be performed separately on the collected tissue sample in a laboratory setting, likely using other IVD devices or methods.
N/A
Intended Use / Indications for Use
When used with a compatible electrosurgical unit, endoscope and patient grounding pad, electric biopsy forceps are intended for electrocautery and removal of polyps and/or tissue within the gastrointestinal tract. The forceps are prescription devices intended for a single patient use only.
Product codes
NLU, KGE
Device Description
Biopsy forceps are devices used to collect tissue samples and/or remove polyps within the gastrointestinal tract via the operating channel of endoscopic instruments.
Electric biopsy forceps include an electrocautery function when used with a compatible electrosurgical unit.
The devices consist of flexible, electrically isolated sheaths with distal grasping cups that are controlled by a proximal handle. The forceps are guided by endoscopy through a biopsy channel with a minimum dimension of 2.8 mm. Monopolar electrocautery requires electrical connection of the forceps to a compatible electrosurgical unit and use of an appropriate patient grounding pad.
Vanguard receives previously used electric biopsy forceps from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the forceps; and returns them to the healthcare facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
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)
Decontamination and cleaning, packaging and sterilization validations and functional/performance, shelf life and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective.
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles facing to the right, representing people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2004 NOV
Heather Crawford, RAC Director of Regulatory Affairs Vanguard Medical Concepts, Inc 5307 Great Oak Drive LAKELAND FL 33815
K011800 - Supplemental Validation Submission Re: Trade/Device Name: See Enclosed List Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: NLU Dated: September 7, 2001 Received: September 10, 2001
Dear Ms. Crawford:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on September 10, 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. Heather Crawford
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 (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.
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 vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
·Attachment 1
The following list is the models used in this submission.
K011800: Vanguard Reprocessed Electric Biopsy Forceps
Microvasive® Radial Jaw 3, Model 1550 Bard Precisor, Model 852 Bard Precisor, Model 853 Bard Precisor, Model 854 Bard Precisor, Model 856
3
Indications for Use
4011800 510(k) Number:
Device Name: Vanguard Reprocessed Electric Biopsy Forceps
Indications for Use:
When used with a compatible electrosurgical unit, endoscope and patient grounding pad, electric biopsy forceps are intended for electrocautery and removal of polyps and/or tissue within the gastrointestinal tract. The forceps are prescription devices intended for a single patient use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Nancy C. Brogdon
f Reproductive, Abdor rical Device
iv
4
SEP 2 7 2001
K011800
Page 1 of 2
510(k) Summary of Safety & Effectiveness
:
:
| Submitter | Vanguard Medical Concepts, Inc.
5307 Great Oak Drive
Lakeland, FL 33815 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Mike Sammon, Ph.D.
Director, Research & Development
(863) 683-8680, extension 228
mikes@safe-reuse.com |
| Date | May 31, 2001 |
| Devices | Trade Names: Vanguard Reprocessed Electric Biopsy Forceps
⇒ Boston Scientific Microvasive® Radial Jaw® 3, and
⇒ C.R. Bard Precisor® Electric Biopsy Forceps Common Name: Electric biopsy forceps Classification: 21 CFR 876.4300 - Endoscopic Electrosurgical Unit and
Accessories - Class II Product Code KGE |
| Predicate
Devices | Boston Scientific Microvasive® Radial Jaw® 3 Electric Biopsy Forceps
believed to be legally marketed under 510(k) premarket notification
K860366 C.R. Bard Precisor® Hot Biopsy Forceps believed to be legally marketed
under 510(k) premarket notification K912601 |
| Indications for
Use | When used with a compatible electrosurgical unit, endoscope and patient
grounding pad, electric biopsy forceps are intended for electrocautery and
removal of polyps and/or tissue within the gastrointestinal tract. The forceps
are prescription devices intended for a single patient use only. |
| Device
Description | Biopsy forceps are devices used to collect tissue samples and/or remove
polyps within the gastrointestinal tract via the operating channel of
endoscopic instruments.
Electric biopsy forceps include an electrocautery function when used with a
compatible electrosurgical unit.
The devices consist of flexible, electrically isolated sheaths with distal
grasping cups that are controlled by a proximal handle. The forceps are
guided by endoscopy through a biopsy channel with a minimum dimension of
2.8 mm. Monopolar electrocautery requires electrical connection of the
forceps to a compatible electrosurgical unit and use of an appropriate patient
grounding pad.
Vanguard receives previously used electric biopsy forceps from healthcare
facilities; cleans, inspects, tests, repackages and sterilizes the forceps; and
returns them to the healthcare facility. |
| Technological
Characteristics | The technological characteristics of the Vanguard reprocessed electric biopsy
forceps are the same as the predicate devices, the original equipment
manufacturer (OEM) electric biopsy forceps. The materials and dimensions
are unchanged and the physical characteristics, performance specifications,
and all other characteristics are essentially identical. |
| Test Data | Decontamination and cleaning, packaging and sterilization validations and
functional/performance, shelf life and biocompatibility testing demonstrates
that the reprocessed devices perform as intended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial
Equivalence" Decision Making Process Chart, we conclude that the Vanguard
reprocessed electric biopsy forceps are substantially equivalent to the
predicate device, the respective OEM biopsy forceps under the Federal Food,
Drug and Cosmetic Act. |
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