(231 days)
Not Found
No
The device description focuses on the mechanical components and materials of a snare set, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
This device is for retrieving and manipulating foreign objects and assisting with other vascular procedures, not for treating a disease or condition.
No
The device is described as a "Multi-Snare Set" intended for retrieval and manipulation of foreign objects, creating loops, repositioning catheters, and assisting with venipuncture. These are interventional and manipulative actions, not diagnostic ones. There is no mention of it being used to diagnose or detect medical conditions.
No
The device description clearly outlines physical components such as wires, coils, a shaft body, and an introducer sheath, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described (retrieval and manipulation of foreign objects, creating loops, repositioning catheters, assisting venipuncture) are all interventional procedures performed directly on or within the patient's body.
- Device Description: The device is a physical tool (snare set and introducer sheath) designed for mechanical manipulation within the vascular system and hollow viscera.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for in vivo (within the body) use.
N/A
Intended Use / Indications for Use
The Multi-Snare Set is designed for the following indications:
- Retrieval and manipulation of foreign objects from the vascular system and hollow . viscera
- Assistance in creating loops where cross-over-technique is applied .
- Repositioning of indwelling venous catheters .
The Multi-Snare Set (and its components) is intended for:
- Retrieval and manipulation of foreign objects from the vascular system and hollow viscera .
- Assistance in creating loops where cross-over technique is applied .
- Repositioning of indwelling venous catheters .
- Assistance in performing venipuncture to obtain access to central vein .
Product codes (comma separated list FDA assigned to the subject device)
74 MMX
Device Description
The pfm Multi-Snare Set is contains of the following parts:
- Inner wire which forms the loop; ●
- Coil mounted on the inner wire in the loop section; .
- Shaft body consisting of an outside coil and a core wire; and .
- Transition from loop wire to shaft body. ●
The Multi-Snare Set consists of a highly elastic Nitinol wire with a pre-formed loop on its distal end. The ware of the snare's highly elastic design, the snare can be introduced through an insertion sheath. The diameter of the snare can be adjusted depending on the position of the sheath. For better manipulation and torque-ability a torquer is provided.
The introducer sheath is designed for interventional insertion of instruments and systems into the vascular system.
The insertion sheath consists of polyethylene tubing, which is curved at its distal end and has a luer adapter at its proximal end. For better visualization the introducer sheath has an additional distal radiopaque marker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system, hollow viscera, central vein
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.
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
510(k) Summary of Safety and Effectiveness
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
| Name: | pfm Produkte f ür die Medizin AG |
|---|---|
| Address: | Wankelstr. 60 |
| 50996 Cologne | |
| Germany | |
| CONTACT PERSON: | Salvadore F. Palomares, RAC |
JAN 24 2002
510(k) Summary of Safety and Effectiveness
JTD(K) Summary of Salety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K011783 Multi-Snare Set Trade Name: Embolectomy Catheter Common Name: Classification Name: Same
Equivalent Devices:
| Manufacturer: | Microvena Corporation |
|---|---|
| Name: | Microsnare |
| 510(k) #: | K925439 |
| Manufacturer: | Cook Inc. |
| Name: | Welter Snare Retriever |
| 510(k) #: | K920823 |
Device Description:
The Multi-Snare Set is designed for the following indications:
- Retrieval and manipulation of foreign objects from the vascular system and hollow . viscera
- Assistance in creating loops where cross-over-technique is applied .
- Repositioning of indwelling venous catheters .
The pfm Multi-Snare Set is contains of the following parts:
- Inner wire which forms the loop; ●
- Coil mounted on the inner wire in the loop section; .
- Shaft body consisting of an outside coil and a core wire; and .
- Transition from loop wire to shaft body. ●
The Multi-Snare Set consists of a highly elastic Nitinol wire with a pre-formed loop on its distal end. The ware of the snare's highly elastic design, the snare can be introduced through an insertion sheath. The diameter of the snare can be adjusted depending on the position of the sheath. For better manipulation and torque-ability a torquer is provided.
The introducer sheath is designed for interventional insertion of instruments and systems into the vascular system.
The insertion sheath consists of polyethylene tubing, which is curved at its distal end and has a luer adapter at its proximal end. For better visualization the introducer sheath has an additional distal radiopaque marker.
Intended Use:
The Multi-Snare Set (and its components) is intended for:
- Retrieval and manipulation of foreign objects from the vascular system and hollow viscera .
- Assistance in creating loops where cross-over technique is applied .
- Repositioning of indwelling venous catheters .
- Assistance in performing venipuncture to obtain access to central vein .
Biocompatibility:
The materials used to manufacture the Multi-Snare Set comply with the requirements of ISO 1093-1.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2002
Mr. Salvadore F. Palomares Regulatory Consultant for pfm PFM Produkte Fur Die Medizen AG C/O Salvadore F. Palomares, RAC 15 Cherokee Streeet Trabuco Canyon, CA 92679
Re: K011783
Trade Name: Multi-Snare Ser Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: 74 MMX Dated: January 17, 2002 Received: January 18, 2002
Dear Mr. Palomares:
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 for use surve in the encreations) it etgansy actment 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
2
Page 2 - Mr. Salvadore F. Palomares
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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) 594-4586. 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 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,
Bram Zuckerman, M.D.
Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K011783 510(k):
Multi-Snare Set Device Name:
The Multi-Snare Set (and its components) is Indications for Use: intended for: Retrieval and manipulation of foreign objects from the vascular system and hollow viscera Assistance in creating loops where cross-over technique is applied Repositioning of indwelling venous catheters Assistance in performing venipuncture to obtain access to central vein
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over the Counter Use
(Division Sign-On)
Division of Dental Infection Control, and
General Hospital Devices
Or
510(K) K011783 Number
Division of Cardiovascular & Respiratory Devices
510(k) Number K011783