(65 days)
Not Found
No
The summary describes a mechanical retrieval snare and provides no indication of AI/ML technology.
Yes
The device is indicated for grasping and retrieval of foreign bodies within the alimentary tract, which is a therapeutic intervention aimed at treating medical conditions or diseases.
No
The Retrieval Snare is described as a tool for grasping and retrieving foreign bodies, which is a therapeutic or interventional function, not a diagnostic one.
No
The device is described as a "Retrieval Snare" and is indicated for grasping and retrieval of foreign bodies. This description strongly suggests a physical, mechanical device, not software. The predicate devices listed are also physical snares.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to grasp and retrieve foreign bodies within the alimentary tract. This is a direct intervention on a patient's body, not a test performed on a sample taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly describes a physical tool for retrieval.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of samples
- Using reagents or assays
The device described is a surgical or interventional device used for removing foreign objects from the body.
N/A
Intended Use / Indications for Use
The Retrieval Snare is indicated for use in grasping and retrieval of foreign body within the alimentary tract. These foreign bodies may include guidewires, pullwires, or plastic stents.
Product codes
78 FDI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary 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)
Not Found
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
§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
NOV 22 1996
8112 SECTION 8 510(K) SUMMARY
1963750
FOLRELEASABLE
David San Daniel March 18 September 1
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
| COMMON/USUAL NAMES: | Snare, Flexible | ||
|---|---|---|---|
| TRADE/PROPRIETARY NAME: | Retrieval Snare | ||
| CLASSIFICATION NAME & | |||
| DEVICE CLASSIFICATION: | Class II | ||
| Name | Number | 21 CFR Ref. | |
| Snare, Flexible | 78 FDI | 876.4300 | |
| DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU) | ||
| Gastro Renal (GRDB) | |||
| OWNER/OPERATOR: | Boston Scientific Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 | |||
| CONTACT PERSON: | Lisa M. Quaglia, Regulatory Affairs Specialist |
INDICATIONS FOR USE
エリ・スー
A UVO DOU 2000
The Retrieval Snare is indicated for use in grasping and retrieval of foreign body within the alimentary tract. These foreign bodies may include guidewires, pullwires, or plastic stents.
CONTRAINDICATIONS
There are no known contraindications for this device.
POTENTIAL COMPLICATIONS
Possible complications include, but may not be limited to: inadvertent perforation during retrieval.
Premarket Notifiontion, Retrieval Snare, November 20, 1906
Promarket Notification, Retrieval Snare, November 20, 1990
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T2:42
K963750
8292
Figure 8-1: Similarities and Differences retween Retrieval Snare, Boston Scientific's Snare, Profile Polypectomy Snare, and Retrieval Loop
| | Microvasive
Retrieval Snare | BSC's Snare | BSC's Profile
Polypectomy
Snare | BSC's Retrieval
Loop |
|-----------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| | (This 510(k)) | (K950496) | (K941750) | (K860269) |
| USE | | | | |
| Indication | Retrieval of
foreign body such
as guidewires,
pullwires, or
plastic stents. | Resection,
removal and
cauterization of
structures such as
polyps, tissue,
lesions or small
tumors. | Removal and
cauterization of
sessile,
diminutive, and
pedunculated
polyps. | Removal of foreign
bodies, stones,
PEG tubes, and
stents. |
| Catheter | | | | |
| Usable Length
(cm) | 180 | 40 to 240 | 240 | 190 |
| Sheath OD
(mm) | 1.9 or 2.3 | 1.9 or 2.3 | 1.9 | 1.7 |
| | | | | |
| Handle Type | Plastic Three-Ring | Plastic Three-Ring | Plastic Three-ring | Plastic Three-Ring |
| Loop Diameter | 11 - 33 mm | 11 - 33 mm | 11-33 mm | 3/8" |
| Loop Shapes | Oval, Crescent, or
Hexagonal | Oval, Crescent, or
Hexagonal | Oval, Crescent,
or Hexagonal | Oval |
BSC = Boston Scientific Corporation