(67 days)
K0000297, K070881
Not Found
No
The summary describes a mechanical device for hemorrhoid ligation and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is used to treat hemorrhoids by cutting off blood flow to the tissue, which is a therapeutic action.
No
The device is used to treat hemorrhoids by cutting off blood flow, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a "simple handheld device" and a "disposable device" supplied with "preloaded non-latex rubber bands," indicating it is a physical, hardware-based medical device. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Haemoband Multi-Ligator Function: The Haemoband Multi-Ligator is a surgical device used to physically treat hemorrhoids by applying a ligature (rubber band) to cut off blood flow. It directly interacts with tissue within the body and performs a therapeutic action.
- No Sample Analysis: The description does not mention any analysis of samples taken from the patient. The device is used directly on the hemorrhoidal tissue.
Therefore, the Haemoband Multi-Ligator falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Haemoband Multi-Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base.
It is for use only by trained medical personnel.
Product codes (comma separated list FDA assigned to the subject device)
FHN
Device Description
The Haemoband Multi-Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue.
The Haemoband Multi-Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with 4 preloaded non-latex rubber bands.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hemorrhoidal tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical personnel located in hospitals, clinics, and doctors' offices.
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.
K0000297, K070881
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
Premarket Notification 510(k) Section 5 - 510(k) Summary
Haemoband
510(k) Summary Page 1 of 3 21-May-09
| Haemoband Surgical Ltd.
The Mount Business Park
2 Woodstock Link
Belfast BT6 8DD
| Northern Ireland |
|---|
| Tel - 011-44-28-9073-7283 |
| Fax - 011-44-28-9073-7282 |
| JUL 2 8 2005 |
| Official Contact: |
| Colin Foster - Managing Director |
| Proprietary or Trade Name: |
| Multi-Ligator |
| Common/Usual Name: |
| Hemorrhoidal ligators |
| Classification Name/Code: |
| 78 FHN - hemorrhoidal ligators |
| 21 CFR 876.4400 |
| Device: |
| Multi-Ligator |
| Predicate Devices: |
| K0000297 - Erchinger Medizintecknik - Ligator |
| K070881 - SAPI MED S.p.a. - LEM ligator |
Device Description:
The Haemoband Multi-Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue.
The Haemoband Multi-Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with 4 preloaded non-latex rubber bands.
Indications for Use:
The Haemoband Multi-Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base.
It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
Patient Population:
Individuals with hemorrhoids
Environment of Use:
Hospitals, clinics, and doctors' offices.
Contraindications
Do not use to treat:
- . 4th degree or continuously prolapsed hemorrhoids
- . Anal Polyps
- In the presence of perineal infection, can be used after the infection has settled. .
- Use with caution when treating patients on anticoagulants i.e. Warfarin .
1
Premarket Notification 510(k) Section 5 — 510(k) Summary
Haemoband
510(k) Summary Page 2 of 3 21-May-09
Summary of substantial equivalence:
| 510(k) Numbers & Manufacturers | Proposed Device | Predicate Device | |
|---|---|---|---|
| K070881 | |||
| SAPI MED S.p.a. | K000297 | ||
| Erchinger Medizintechnik | |||
| Device | Haemoband Multi-Ligator | LEM | Ligator |
| Class | Class II | Class II | Class II |
| Product Code | FHN | FHN | FHN |
| CFR | 876.4400 | 876.4400 | 876.4400 |
| Intended Use | The Haemoband Multi-Ligator | ||
| includes suction and ligation | |||
| capabilities. The ligator is used | |||
| to cut off the blood flow to | |||
| hemorrhoidal tissue by means of | |||
| a ligature or ring placed around | |||
| the hemorrhoid base. | The LEM Hemorrhoidal | ||
| ligators are used to cut off | |||
| the blood flow to | |||
| hemorrhoidal tissue by | |||
| means of a ligature or ring | |||
| placed around the | |||
| hemorrhoid base. | Hemorrhoidal ligators are | ||
| used to cut off the blood | |||
| flow to hemorrhoidal tissue | |||
| by means of a ligature or | |||
| ring placed around the | |||
| hemorrhoid base. | |||
| Environment of Use | Hospitals, clinics, and doctors' | ||
| offices. | Not specified | Not specified | |
| Prescriptive | Yes trained medical personnel | Yes trained medical | |
| personnel trained in | |||
| proctology | Yes trained medical | ||
| personnel trained in | |||
| proctology | |||
| Principle of Operation | Apply a ligature or elastic ring | ||
| around the base of the | |||
| hemorrhoidal nodule in order to | |||
| cut off the blood flow to the | |||
| hemorrhoidal tissue. Has a | |||
| means to apply suction to hold | |||
| the hemorrhoidal tissue prior to | |||
| and during the ligature | |||
| procedure. Pre-loaded bands in a | |||
| pistol handgrip with trigger to | |||
| apply suction and release the | |||
| banding ring | Apply a ligature or elastic | ||
| ring around the base of the | |||
| hemorrhoidal nodule in | |||
| order to cut off the blood | |||
| flow to the hemorrhoidal | |||
| tissue. Has a means to | |||
| apply suction to hold the | |||
| hemorrhoidal tissue prior | |||
| to and during the ligature | |||
| procedure. Pre-loaded | |||
| bands in a pistol handgrip | |||
| with trigger to apply | |||
| suction and release the | |||
| banding ring | Hemorrhoid is grasped with | ||
| a forceps or sucked into the | |||
| ligator head (suction | |||
| forceps). A ring is slipped | |||
| over the varicosity, causing | |||
| tissue necrosis and | |||
| sloughing of the | |||
| hemorrhoid. | |||
| Disposable | Single patient use, disposable | Single patient use, | |
| disposable | Surgical stainless steel, | ||
| reusable | |||
| Materials | Standard materials tested or | ||
| certified to ISO 10993 | |||
| Bands identical to K000297 | Not known | Identical bands used in | |
| proposed device. | |||
| 510(k) Numbers & | |||
| Manufacturers | K070881 | ||
| SAPI MED S.p.a. | K000297 | ||
| Erchinger Medizintechnik | |||
| Device | Haemoband Multi-Ligator | LEM | Ligator |
| Preloaded ready for | |||
| use | Yes | No but supplied with a | |
| band loader | No | ||
| Multi bands | Yes | No | No |
| Auto reload | Yes | No | No |
| Suction | Integrated | Yes | Yes |
·
.
62
2
Premarket Notification 510(k) Section 5 - 510(k) Summary
Haemoband
510(k) Summary Page 3 of 3 21-May-09
It is our view that there are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.
Substantial Equivalence
The Haemoband Multi-Ligator is viewed as substantially equivalent to the predicate devices because:
Indications -
- Identical to predicate K070881 SAPI Med LEM .
Technology -
.
Materials -
- The materials in patient contact are identical to predicate device or we have provided . ISO 10993 certification.
Environment of Use -
- Identical to predicate K000297 Erchinger .
3
Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Haemoband Surgical Ltd. c/o Mr. Paul E. Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134-29158
JUL 28 2009
Re: K091519
Trade/Device Name: Haemoband Multi-Ligator Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class; II Product Code: FHN Dated: May 21, 2009 Received: May 22, 2009
Dear Mr. Dryden:
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); medical device reporting of medical
4
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Iadine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number:
(To be assigned)
510(k) Number:
Device Name:
Haemoband Multi-Ligator
Indications for Use:
The Haemoband Multi-Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base.
It is for use only by trained medical personnel.
Prescription Use XX . (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hula Remu
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
A