(77 days)
Not Found
Lacrimal Intubation Set manufactured and distributed by JEDMED, Canaliculus Intubation Set manufactured and distributed by SOLAN, Lacrimal Intubation Set and DCR Set manufactured and distributed by VISITEC
No
The summary describes a physical surgical device for lacrimal system reconstruction and does not mention any software, image processing, or AI/ML terms.
Yes
The device is used in ophthalmic surgery to reconstruct the lacrimal outflow system, which is a medical intervention aimed at treating a health condition.
No
The device is described as being used for surgical reconstruction (dacryocystorhinostomy and other lacrimal system reconstruction), which is a treatment, not a diagnostic process.
No
The device description clearly states it consists of "two pieces of the same gauge size and leagues statules" and describes physical joining methods ("frietion fft, gluing, or crimping"), indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical reconstruction of the lacrimal outflow system. This is a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as physical pieces used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside that definition.
N/A
Intended Use / Indications for Use
These devices are by an oculoplastic surgeon to reconstruct the lacmal of the constigution of Intended Use: Intess devices are of an Oculopastic surveystominostomy which is the construction The injury of mairormation of the lacimal dramacal sac into the nose , and other lacimal system reconstruction.
and
These devices are used in ophthalmic surgery to reconstruct the lacrimal outflow system, dacryocystorhinostomy, and other lacrimal system reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
OKS
Device Description
The referenced devices consist of two pieces of the same gauge size and leagues statules. Description: The reterenced devices consist of two pieces of the same from the relations two by frietion fft, gluing, or crimping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lacrimal outflow system, lacrimal sac, nose, tear drainage channel, canaliculi
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Oculoplastic surgeon / ophthalmic surgery
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.
Not Found
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.
Lacrimal Intubation Set manufactured and distributed by JEDMED, Canaliculus Intubation Set manufactured and distributed by SOLAN, Lacrimal Intubation Set and DCR Set manufactured and distributed by VISITEC
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
N/A
0
Hurricane Medical 2331K 63td Avenue East Bradenton, FL 34203 941-751-0588 FAX 941-752-4738
MAY 1 8 1999
510(k) Summary Lacrimal Intubation Sets and DCR Sets
March 26, 1999 Contact Person: David A. Clapp
CONFIDENTIAL
Classification Name: Unknown Classification Name: Onknown
Common Name: Lacrimal Intubation Set, Dacryocystorhinostomy (DCR) Set
Classification: Unknown
Substantial Equivalent: The referenced devices manufactured and distributed by Hurricane Medical are substantially equivalent to:
Lacrimal Intubation Set manufactured and distributed by JEDMED
Canaliculus Intubation Set manufactured and distributed by SOLAN
Lacrimal Intubation Set and DCR Set manufactured and distributed by VISITEC
Description: The referenced devices consist of two pieces of the same gauge size and leagues statules. Description: The reterenced devices consist of two pieces of the same from the relations two by frietion fft, gluing, or crimping.
Intended Use: These devices are by an oculoplastic surgeon to reconstruct the lacmal of the constigution of Intended Use: Intess devices are of an Oculopastic surveystominostomy which is the construction The injury of mairormation of the lacimal dramacal sac into the nose , and other lacimal system reconstruction. The stainless steel probe followed by the silicone tubing is used by the oculoplastic surgete of the tass deming of stamless steel probe toulowed by the sincole tason of are over at the oney on the tear darage channel inside the nasal cavity and is removed from the silicone tubing. The silicone tubing is scured and left in channel inside the nasal carry and is removed nom the oculoplastic surgeon determines when the silicone tubing is removed.
Literature Review:
During the past several decades, several methods and materials have been used to temporarily splint portions of the lacrimal drainage system as treatment for injuries or obstructions.
In 1959, Huggert first described intubation of the lacrimal drainage system. Acta Ophthalmology, 1959, 37:35-358.
In 1977, Crawford described a method for intubating the lacrimal system by using silicone tubing attacted to and stainless steel probe on each end. After inserting the probes through the canaliculi into the nots of the ends of the They were then left in place for up to six months. Canadian Journal of silicone were cut and tied. Ophthalmology, 1977; 12:289-292.
1
CONFIDENTIAL
Dacryocystortiinostomy (DCR) as defined in the Dictionary of Eye Terminology is the construction of a new tear drainage channel from the lacrimal sac into the nose. Hurwitz describes a DCR procedure in which the silicone tubing is left in place for four months. Canadian Journal of Ophthalmology, 1982; 17:13-16.
Flanagan describes a DCR procedure where the silicone tubes were left in place for six months to allow scar tissue to form. Oculoplastic Surgery Strabismus and Pediatric Ophthalmology, 1990.
Reifler reports that silicone tubing has achieved great popularity and is viewed by many experts as the canalicular stent material of choice.
| Characteristic | Hurricane Medical | JEDMED | SOLAN | VISITEC |
|---|---|---|---|---|
| Probe Material | Stainless Steel Wire | Stainless Steel Wire | Stainless Steel Wire | Stainless Steel Wire |
| Probe Size (DxL) | 0.025" x 7" | 0.016" x 4" | 0.051" x 6" | 0.025" x 7" |
| Probe Size (DxL) | 0.90" x 1.75" | N/A | N/A | 0.90" x 1.75" |
| Tubing Matcrial | Medical Grade Silicone | Medical Grade Silicone | Silicone | Silicone |
| Rod Material | Medical Grade Silicone | Medical Grade Silicone | Silicone | Silicone |
| Tubing Size (DxL) | 0.025" x 13" | 0.025" x unknown | Unknown x 12" | 0.025" x 14" |
| Rod Size (DxL) | 0.080" x 15" | N/A | N/A | 0.080" x 15" |
| Adhesive Used | Yes | Yes | Yes | Yes |
| Probe Ends | Rounded/Blunt | Olive Shaped (Rounded) | Rounded/Blunt | Rounded/Blunt |
| Probe Malleability | Excellent | Excellent | Excellent | Excellent |
| Surgical Uses | Single | Single | Single | Single |
| Package Type | Tyvek Pouch | Tyvek Pouch | Tyvek Pouch | Tyvek Pouch |
| Packaged Sterile | Yes | Yes | Yes | Yes |
Technological characteristics as compared to predicate devices:
Safety Charactoristics: These devices are used only by oculoplastic surgeons who are experts in this dicipline of reconstructive surgery. The use of a malleable stainless steel probe allows the surgeon to form the probe as needed. The probes contain a radius/blunt end to allow a smooth passage through the tear drainage channel. The silicone tubing following the stainless steel probe contains an equal or less diameter than the stainless steel probe. This allows the silicone tubing to easily follow the probe. The silicone tubing is friction fitted over the stainless steel probe as well as bonded with glue. This minimizes the risk of the silicone tubing becoming seperated from the stainless steel probe during the navigation through the tear drainage channel. The silicone tubing and adhesive are medical grade. The devices are packaged in water impermable and tear resistant tyvel