(77 days)
These devices are used in ophthalmic surgery to reconstruct the lacrimal outflow system, dacryocystorhinostomy, and other lacrimal system reconstruction.
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.
{
"1_table_of_acceptance_criteria_and_the_reported_device_performance": {
"Characteristic": [
"Probe Material",
"Probe Size (DxL)",
"Probe Size (DxL)",
"Tubing Matcrial",
"Rod Material",
"Tubing Size (DxL)",
"Rod Size (DxL)",
"Adhesive Used",
"Probe Ends",
"Probe Malleability",
"Surgical Uses",
"Package Type",
"Packaged Sterile"
],
"Hurricane Medical": [
"Stainless Steel Wire",
"0.025" x 7"",
"0.90" x 1.75"",
"Medical Grade Silicone",
"Medical Grade Silicone",
"0.025" x 13"",
"0.080" x 15"",
"Yes",
"Rounded/Blunt",
"Excellent",
"Single",
"Tyvek Pouch",
"Yes"
],
"JEDMED": [
"Stainless Steel Wire",
"0.016" x 4"",
"N/A",
"Medical Grade Silicone",
"Medical Grade Silicone",
"0.025" x unknown",
"N/A",
"Yes",
"Olive Shaped (Rounded)",
"Excellent",
"Single",
"Tyvek Pouch",
"Yes"
],
"SOLAN": [
"Stainless Steel Wire",
"0.051" x 6"",
"N/A",
"Silicone",
"Silicone",
"Unknown x 12"",
"N/A",
"Yes",
"Rounded/Blunt",
"Excellent",
"Single",
"Tyvek Pouch",
"Yes"
],
"VISITEC": [
"Stainless Steel Wire",
"0.025" x 7"",
"0.90" x 1.75"",
"Silicone",
"Silicone",
"0.025" x 14"",
"0.080" x 15"",
"Yes",
"Rounded/Blunt",
"Excellent",
"Single",
"Tyvek Pouch",
"Yes"
]
},
"2_sample_sized_used_for_the_test_set_and_the_data_provenance": "The document describes a 510(k) submission for substantial equivalence based on technological characteristics and literature review, not a clinical study with a test set of patient data. Therefore, this information is not applicable.",
"3_number_of_experts_used_to_establish_the_ground_truth_for_the_test_set_and_the_qualifications_of_those_experts": "The document describes a 510(k) submission for substantial equivalence based on technological characteristics and literature review, not a clinical study with a test set requiring expert ground truth. Therefore, this information is not applicable.",
"4_adjudication_method_for_the_test_set": "The document describes a 510(k) submission for substantial equivalence based on technological characteristics and literature review, not a clinical study with a test set requiring adjudication. Therefore, this information is not applicable.",
"5_if_a_multi_reader_multi_case_MRMC_comparative_effectiveness_study_was_done_If_so_what_was_the_effect_size_of_how_much_human_readers_improve_with_AI_vs_without_AI_assistance": "No MRMC comparative effectiveness study was done. This is a 510(k) submission for a medical device (lacrimal intubation sets and DCR sets), not an AI-based diagnostic or assistive technology. The evaluation is based on substantial equivalence to predicate devices.",
"6_if_a_standalone_i.e._algorithm_only_without_human-in-the_loop_performance_was_done": "No standalone algorithm-only performance study was done. This is a 510(k) submission for a medical device (lacrimal intubation sets and DCR sets), not an AI-based system. The evaluation is based on substantial equivalence to predicate devices.",
"7_the_type_of_ground_truth_used": "The concept of 'ground truth' as it applies to clinical study outcomes or diagnostic accuracy is not directly applicable here. The 'ground truth' for this 510(k) submission is the functional and safety characteristics of existing legally marketed predicate devices, against which the new device (Hurricane Medical's sets) is compared for substantial equivalence.",
"8_the_sample_size_for_the_training_set": "The document does not describe a training set as would be used for an AI/ML model or a clinical trial. The assessment is based on a comparison of technological characteristics to already marketed predicate devices and a literature review. Therefore, this information is not applicable.",
"9_how_the_ground_truth_for_the_training_set_was_established": "The document does not describe a training set as would be used for an AI/ML model or a clinical trial. The assessment is based on a comparison of technological characteristics to already marketed predicate devices and a literature review, not a training set with established ground truth. Therefore, this information is not applicable."
}
{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</poly pouches that are heat sealed. The sterilization process ensures at least a 10 sterility assurance level (SAL).
The literature review included in this summary has demonstrated that information regarding surgery to the lacrimal system has been published as far back as 1959. Devices used in these surgical procedures were commonly constructed from stainless steel wire and silicone tubing. The referenced literature has also shown that the referenced device may be safely and effectively be used by a competent oculoplastic surgeon to reconstruct the lacrimal outflow system, dacryocystorhinostomy, and other lacrimal system reconstruction many situations that are deemed appropriate.
The Hurricane Medical Lacrimal Intubation Sets and Dacryocystorhinostomy (DCR) Sets have equivalent technological characteristics as the proposed predicate devices. Each identified can be seen in the above chart and thus demonstrates substantial equivalence to a legally marketed device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal features a stylized eagle with its head turned to the right. The eagle's body is formed by three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
DEC 112008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
David A. Clapp Regulatory Affairs Head Official Correspondent Hurricane Medical 2331K 63td Avenue East Bradenton, FL 34203
Re: K990672 and A1 and A2 Trade/Device Name: Lacrimal Intubation Set and Dacryocystorhinostomy (DCR) Set Regulatory Class: Unclassified Product Code: OKS Dated: February 23, March 9, and March 26, 1999 Received: March 2, and March 12, and April 5, 1999
Dear Mr. Clapp:
This letter corrects our substantially equivalent letter of May 18, 1999.
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 (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 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Malvina B. Epler, ud
Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number : K990672
Device Name: Lacrimal Intubation Set, DCR Set
Indications For Use:
These devices are used in ophthalmic surgery to reconstruct the lacrimal outflow system, dacryocystorhinostomy, and other lacrimal system reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, office of Device Evaluation (ODE)
Prescription Use &
or
Over-the -counter use
Casi
ision Sige-Off)
Division of Ophthalmic Devices
510(k) Numbon
COO
$10(k) Number_k Gr
N/A