(59 days)
No
The summary describes a mechanical surgical device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for nasolacrimal intubation to address conditions such as canalicular pathologies and lacrimal duct obstruction, which are medical conditions, and thus performing a therapeutic function.
No.
The device is described as an ophthalmic surgical device used for nasolacrimal intubation to address canalicular pathologies, dacryocystorhinostomy, and congenital lacrimal duct obstruction. Its intended use is for treatment, not diagnosis. The performance studies mentioned focus on mechanical equivalence to a predicate device, not diagnostic accuracy.
No
The device description explicitly states it is a "hand held, and ophthalmic surgical device" consisting of a silicone tube, stainless steel probes, and a plastic handled retriever with a stainless steel hook. These are physical components, not software.
Based on the provided information, the Oasis Medical Lacrimal Intubation Set 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.
- Device Function: The description clearly states that the Oasis Medical Lacrimal Intubation Set is a "hand held, and ophthalmic surgical device" used by a physician for "nasolacrimal intubation." This is a surgical procedure performed directly on the patient's body to address issues with the tear drainage system.
- No Sample Analysis: The device does not involve the analysis of any samples taken from the patient's body.
Therefore, the device falls under the category of a surgical instrument used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Oasis Medical Lacrimal Intubation Set is intended for use for nasolacrimal intubation in patients of age and older. Indications for nasolacrimal intubation performed with the Oasis Medical Lacrimal Intubation device are:
- Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations)
- During dacryocystorhinostomy
- Congenital lacrimal duct obstruction
Product codes
OKS
Device Description
The Oasis Lacrimal Intubation Set with Retrieval Device (Model Summary: 6004) is a sterile (via gamma sterilization-VDmax method-25kGy), single-use, hand held, and ophthalmic surgical device. The device consists of a twelve inch medical grade silicone tube that is secured at each end to two 4 ½", 23 gauge stainless steel, olive-tipped probes along with a 3″ plastic handled retriever with a stainless steel hook. The Oasis Lacrimal Intubation Set with Retrieval Device is used by a physician for nasolacrimal intubation. The insertion and removal for the Oasis Lacrimal Intubation Set with Retrieval Device is equivalent to the insertion and removal of the predicate device as evident in the IFU for each device. For insertion, each punctum should be dilated and the lacrimal system should be probed to open any blockages by using a standard lacrimal probe. The first probe of the Lacrimal Intubation Set is passed through the upper punctum and across the upper canaliculus and then oriented down through the lacrimal system into the nose approximately 4cm. Proper positioning of the probe can be confirmed by achieving metal-to-metal contact with the retrieval instrument inserted through the nostril. The probe end should be located lateral to the inferior turbinate in the inferior meatus of the nose. The retrieval instrument can be used to engage the probe at its olive tip and pull the probe out of the nose. The second probe is passed down the inferior canaliculus and out of the nose in a similar fashion.
The two exposed probes are cut from the silicone tube and removed. The ends of the silicone tube are tied to each other and securely knotted. The silicone tubes may be further secured by a tiny suture. Tuck the knotted silicone tubes up into the nose.
For removal, the silicone tube is located in the eye between the upper and lower puncta and pulling the tube upward. The silicone tube is then cut and pulled out completely from the ducts.
The knot used to tie the silicone tubes together is too big to pass through the canaliculus and the silicone tubes must be removed through the nose. In older patients it may be possible to expel the knot by having the patient blow their nose. In small children, location of the knot and silicone tube removal may need to be performed under general anesthesia.
Duration of intubation (patient contact of the silicone tube portion) is 24 hours to 30 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasolacrimal
Indicated Patient Age Range
12 months of age and older
Intended User / Care Setting
physician
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)
The subject device performed equivalently to the predicate device in a series of bench tests which included an assessment of dimensional attributes and device durability via strength testing by means of applying a known pull force on the device junctions. It was concluded in this side-by-side comparison, the subject device and the predicate device have similar safety, effectiveness, and performance profiles because their overall design and strength are equivalent.
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
N/A
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized representation of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2016
Anodyne Surgical Ms. Valerie Anderson Director Quality Assurance and Regulatory Affairs 804 Corporate Centre Drive O' Fallon, Missouri 63368
Re: K160710
Trade/Device Name: Oasis Lacrimal Intubation Set with Retrieval Device Regulation Name: Lacrimal Stents and Intubation Sets Regulatory Class: Unclassified Product Code: OKS Dated: March 14, 2016 Received: March 15, 2016
Dear Ms. Anderson:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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, and 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
1
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) Not known
Device Name
Oasis Lacrimal Intubation Set with Retrieval Device
Indications for Use (Describe)
The Oasis Medical Lacrimal Intubation Set is intended for use for nasolacrimal intubation in patients of age and older. Indications for nasolacrimal intubation performed with the Oasis Medical Lacrimal Intubation device are:
- · Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations)
- · During dacryocystorhinostomy
- · Congenital lacrimal duct obstruction
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Anodyne Surgical. The logo includes the text "PSI / EYE-KO, Inc. dba" in red font at the top right. Below this text is the word "ANODYNE" in large blue font, with the word "SURGICAL" in smaller font below it. There are also red curved lines at the bottom left of the logo.
Oasis Lacrimal Intubation Set with Retrieval Device
510(K) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
| Applicant's Name and
Address: | Anodyne
804 Corporate Centre Drive
O'Fallon, MO 63368 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Valerie Anderson
Director Quality and Regulatory Affairs
(T) 636-447-1010
(F) 636-447-1786 |
| Date Prepared: | May 10, 2016 |
| Device Trade Name: | Oasis Lacrimal Intubation Set with Retrieval Device |
| Common Name: | Lacrimal Intubation Set with Retrieval Device |
| Regulation Number: | Unclassified |
| Regulation Name: | Unclassified |
| Regulatory Class: | Unclassified |
| Product Code: | OKS |
| FDA Panel: | Ophthalmic |
| Predicate Device: | Sold separately - FCI, Crawford Bicanaliculus Intubation
(Unclassified - K121142 - Product Code OKS) and Crawford Hook
(Class 1 - 510(K) Exempt - Product Code HNQ - Reg. Number
886.4350) |
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Image /page/4/Picture/0 description: The image contains the logos for PSI / EYE-KO, Inc. dba and Anodyne Surgical. The PSI / EYE-KO, Inc. dba logo features a red eye with the letters "P.S.I." and a map of the United States inside. The Anodyne Surgical logo features the word "ANODYNE" in blue, with the word "SURGICAL" in smaller letters below it. There are also three red curved lines below the word "ANODYNE".
510(K) Submission Oasis Lacrimal Intubation Set with Retrieval Device 510(K) Summary Submitted in accordance with the requirements of 21 CFR 807.92
Device Description The Oasis Lacrimal Intubation Set with Retrieval Device (Model Summary: 6004) is a sterile (via gamma sterilization-VDmax method-25kGy), single-use, hand held, and ophthalmic surgical device. The device consists of a twelve inch medical grade silicone tube that is secured at each end to two 4 ½", 23 gauge stainless steel, olivetipped probes along with a 3″ plastic handled retriever with a stainless steel hook. The Oasis Lacrimal Intubation Set with Retrieval Device is used by a physician for nasolacrimal intubation. The insertion and removal for the Oasis Lacrimal Intubation Set with Retrieval Device is equivalent to the insertion and removal of the predicate device as evident in the IFU for each device. For insertion, each punctum should be dilated and the lacrimal system should be probed to open any blockages by using a standard lacrimal probe. The first probe of the Lacrimal Intubation Set is passed through the upper punctum and across the upper canaliculus and then oriented down through the lacrimal system into the nose approximately 4cm. Proper positioning of the probe can be confirmed by achieving metal-to-metal contact with the retrieval instrument inserted through the nostril. The probe end should be located lateral to the inferior turbinate in the inferior meatus of the nose. The retrieval instrument can be used to engage the probe at its olive tip and pull the probe out of the nose. The second probe is passed down the inferior canaliculus and out
5
Image /page/5/Picture/0 description: The image contains two logos. The first logo is for "PSI / EYE-KO, Inc. dba" and features a red eye-shaped graphic with the letters "P.S.I." and a map of the United States inside. The second logo is for "ANODYNE SURGICAL" and features the word "ANODYNE" in large blue letters above the word "SURGICAL" in smaller red letters. There are also red curved lines below the words "ANODYNE SURGICAL".
510(K) Submission Oasis Lacrimal Intubation Set with Retrieval Device 510(K) Summary Submitted in accordance with the requirements of 21 CFR 807.92
of the nose in a similar fashion.
The two exposed probes are cut from the silicone tube and removed. The ends of the silicone tube are tied to each other and securely knotted. The silicone tubes may be further secured by a tiny suture. Tuck the knotted silicone tubes up into the nose.
For removal, the silicone tube is located in the eye between the upper and lower puncta and pulling the tube upward. The silicone tube is then cut and pulled out completely from the ducts.
The knot used to tie the silicone tubes together is too big to pass through the canaliculus and the silicone tubes must be removed through the nose. In older patients it may be possible to expel the knot by having the patient blow their nose. In small children, location of the knot and silicone tube removal may need to be performed under general anesthesia.
Duration of intubation (patient contact of the silicone tube portion) is 24 hours to 30 days.
6
Image /page/6/Picture/0 description: The image contains two logos. The first logo is for "PSI / EYE-KO, Inc. dba" and features a stylized eye with the letters "P.S.I." inside, along with an outline of the United States. The second logo is for "ANODYNE SURGICAL" and is written in a bold, sans-serif font, with the word "ANODYNE" in a larger font size than "SURGICAL". There are also red curved lines underneath the word "ANODYNE".
Oasis Lacrimal Intubation Set with Retrieval Device
510(K) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
Indications for Use: The Oasis Medical Lacrimal Intubation Set with Retrieval Device is intended for use for nasolacrimal intubation in patients 12 months of age and older. Indications for nasolacrimal intubation performed with the Oasis Medical Lacrimal Intubation device are:
- Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations)
- During dacryocystorhinostomy
- Congenital lacrimal duct obstruction
The Indications for Use statement for the Oasis Medical Lacrimal Intubation Set with Retrieval Device is equivalent to the predicate device.
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Image /page/7/Picture/0 description: The image shows the logo for Anodyne Surgical. The logo includes the text "PSI / EYE-KO, Inc. dba" in red font at the top right. Below that is the word "ANODYNE" in large blue font, with the word "SURGICAL" in smaller red font below it. There are also red curved lines at the bottom left of the logo.
Oasis Lacrimal Intubation Set with Retrieval Device
510(K) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
| Summary of
Technological
characteristics: | The Oasis Lacrimal Intubation with Retrieval Device is equivalent to
the predicate device in terms of: |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | Oasis Lacrimal Intubation Design – probes and silicone |
| | Mode of Action – intubation of the lacrimal ducts enabling
drainage of tears by capillarity |
| | Instructions for Use – insertion and removal |
| | Oasis Lacrimal Intubation Materials - Stainless steel and
silicone |
| | Differences include: |
| | Retrieval Device Design - The predicate hook is reusable
whereas the Oasis Medical Lacrimal Intubation Set Retrieval |
Device is single-use and disposable (plastic handle). The reusable predicate hook is more substantial (stainless steel handle) for multiple uses. Slightly angled, ergonomic hook on the Oasis Medical Lacrimal Intubation Set Retrieval Device.
Retrieval Device Sterility - The predicate device hook is not provided sterile whereas the Oasis Medical Lacrimal Intubation Set with Retrieval Device is provided sterile.
Mode of Sterilization for Oasis Lacrimal Intubation - The predicate intubation device is EtO sterilized whereas the Oasis Medical Lacrimal Intubation Set with Retrieval Device is gamma sterilized via VDmax method (25kGy).
The device differences do not affect the Oasis Medical Lacrimal Intubation Set with Retrieval Device in terms of relevant functionality and safety.
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Image /page/8/Picture/0 description: The image contains the logos for PSI / EYE-KO, Inc. dba and Anodyne Surgical. The PSI logo features an eye with the letters P.S.I. and an outline of the United States inside. The Anodyne Surgical logo is in blue and red, with the word "ANODYNE" in large, bold letters and the word "SURGICAL" underneath in smaller letters.
Oasis Lacrimal Intubation Set with Retrieval Device
510(K) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
| Biocompatibility: | The biocompatibility evaluation for the Oasis Lacrimal Intubation
with Retrieval Device included the following tests:
Cytotoxicity
Sensitization
Irritation
Test results concluded this device did not elicit an adverse reaction
during the above testing. The silicone tubing is considered the
tissue contacting portion. The duration of contact is 24 hours to
30 days. In consideration of the Oasis Lacrimal Intubation with
Retrieval Device manufacturing process, no novel impurities are
introduced or added to the silicone and therefore the silicone
material biocompatibility profile exceeds USP Class VI. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Non-clinical
tests: | The subject device performed equivalently to the predicate device
in a series of bench tests which included an assessment of
dimensional attributes and device durability via strength testing by
means of applying a known pull force on the device junctions. It
was concluded in this side-by-side comparison, the subject device
and the predicate device have similar safety, effectiveness, and
performance profiles because their overall design and strength are
equivalent. |
| Substantial Equivalence
Basis: | The conclusions performed by independent laboratories and
internal comparative bench testing provide objective evidence to
substantiate the Oasis Lacrimal Intubation Set with Retrieval
Device is as safe and effective as the predicate device that is
currently marketed for the same intended use. |