(28 days)
K944220/A
Not Found
No
The description focuses on mechanical modifications for single-hand operation and use with an anoscope, with no mention of AI or ML.
Yes
The device is used to ligate internal hemorrhoids, which is a therapeutic intervention, meaning it treats a condition.
No
The device is described as being used to "ligate internal hemorrhoids," which is a treatment procedure, not a diagnostic one.
No
The device description clearly details physical components like a handle, barrel, bands, and trigger cord, indicating it is a hardware device used for a physical procedure (ligation). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is used to "ligate internal hemorrhoids." This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Lack of Diagnostic Information: The device's purpose is to treat a condition (hemorrhoids) by physically ligating them. It does not provide any diagnostic information about the patient's health status.
The description focuses on the mechanical function of the device and its use in a surgical setting, which is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
Used to ligate internal hemorrhoids.
Product codes (comma separated list FDA assigned to the subject device)
78 FHN
Device Description
The Wilson-Cook Modified Multiple Band Ligator is used to ligate internal hemorrhoids. This device is supplied non-sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal hemorrhoids
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K944220/A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
MAR 1 9 2002
510 (K) SUMMARY (Based on 21 CFR Part 807.92)
Submitted By: Wilson-Cook Medical Inc. 4900 Bethania Station Road & 5951 Grassy Creek Boulevard Winston-Salem, NC 27105
Device Description:
The Wilson-Cook Modified Multiple Band Ligator is used to ligate internal hemorrhoids. This device is supplied non-sterile and intended for single use only.
| Trade Name: | Wilson-Cook Multiple Band Ligator |
|---|---|
| Common/Usual Name: | Multiple Band Ligator |
| Classification Name/Code: | Ligator, Hemorrhoidal, GU, 78 FHN |
| Classification: | FDA has classified similar devices as |
| Class II, as per 21 CFR § 876.4400. This | |
| device falls within the purview of the | |
| Gastroenterology and Urology Device | |
| Panel. | |
| Performance Standards: | To the best of our knowledge, performance |
| standards for this device do not exist. | |
| Intended Use: | Used to ligate internal hemorrhoids. |
Predicate Device:
| PREDICATE DEVICE | MANUFACTURER | DOCUMENT CONTROL NUMBER |
|---|---|---|
| Wilson-Cook Multiple | ||
| Band Ligator | Wilson-Cook | |
| Medical | K944220/A |
Substantial Equivalence:
The Wilson-Cook Modified Multiple Band Ligator is substantially equivalent to the referenced predicate device with respect to design, materials of construction and intended use.
| DEVICE
CHARACTERISTIC | Wilson-Cook Modified
Multiple Band Ligator
[Subject of Special
510(k)] | Wilson-Cook
Multiple Band Ligator
(K944220/A) |
|--------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used to ligate internal
hemorrhoids. | Used to ligate
esophageal varices at or
above the
gastroesophageal
junction and to ligate
internal hemorrhoids. |
| Sterility | Non-sterile, Disposable | Non-sterile, Disposable |
the predicate Wilson-Cook Multiple Band The modification of Ligator (K944220/A) consists of a change to the handle in order accommodate single-hand operation through an anoscope. to In addition, the modified device comes preloaded with the barrel attached to the tip of the handle. The predicate device is designed for attachment to the end of an endoscope, while the
1
510 (K) SUMMARY (continued)
modified Multiple Band Ligator is used in conjunction with an anoscope .
The barrel and bands of the modified device are identical to the burrer and bands Wilson-Cook Multiple Band Ligator in the chose of the production and the specifications of each. The trigger cord is comprised of the same materials, however the Crigger Cord ID ockparis slightly shorter in length for the vectrail string aacd in brights) - ar need to fit the length of modified devices, as a se the modified device comes production and an chaobeope. Doading catheter and irrigation adapter are not needed.
It is also important to note that both the predicate and the modified device share the same intended use, share similar methods of operation, and are comprised of the same raw materials.
Biocompatibility:
assurance of biocompatibility for for the patient -Reasonable keasonable as been established through a history of contacting mater patient-contacting medical devices and, as applicable, biocompatibility test results.
Design Control/Risk Analysis/Design Verification:
Design Control, Risk Analysis, Design Verification activities for the subject of this special 510(k) have been conducted in accordance with all applicable internal procedures. The design control process employed is inclusive of the elements as stipulated by 21 CFR Part 820.30, as applicable to the project. The risk analysis performed identified the risks relative to the performance requirements, as specified by our internal procedure performance roquis. The failure mode, effect of failure, severity, potential cause, rate of occurrence, design control element/production controls to eliminate, the potential to detect and our recommended actions were also documented. During Design Verification, dimensional and functional testing to ensure the performance and design integrity of this product line were conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2002
Ms. Margaret J. Posner Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105 Re: K020526
Trade/Device Name: Wilson-Cook Multiple Band Ligator (Device Modification) Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: 78 FHN Dated: February 13, 2002 Received: February 19, 2002
Dear Ms. Posner:
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 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
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and in you ding of substantial equivalence of your device to a legally marketed nontheation. The I Dr Intelliges if cation 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), please If you doshe specific ac-ripliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on of folor to premained 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,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 1 | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |||
510(k) Number (if known): _ KOZLES26
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Used to ligate internal hemorrhoids.
(Please do not Write Below This Line – Continue on Another Page, if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| OR | |
| Over-The-Counter | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K020526 |
|---|---|
| --------------- | --------- |