(76 days)
Not Found
Not Found
No
The description focuses on a mechanical process for humidifying air and does not mention any computational or learning capabilities.
No.
The device facilitates a surgical procedure by humidifying air for fluid/air exchange during vitrectomy, but it does not directly treat a disease or condition itself.
No
This device is described as a tubing set used for humidifying air during a vitrectomy procedure, which is a surgical intervention. It plays a role in the treatment process by preventing cataracts, not in diagnosing a condition.
No
The device description clearly describes a physical tubing set with a humidifying filter and injection port, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is used during a surgical procedure (vitrectomy) to infuse fluid and humidified air directly into the eye. It does not analyze any specimens taken from the body.
The device's function is to facilitate a surgical procedure, not to perform diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
For infusion of fluid and air during vitrectomy.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
During a vitrectomy, it is necessary to irrigate balanced salt solution (BSS) into the eye to replace the natural vitreous. If a retinal hole is present, the surgeon must then replace the balanced salt solution (BSS) with air to prevent the fluid from remaining under the retina. One of the problems associated with fluid/air exchange is development of cataracts. The Moistair™ Tubing Set humidifies the dry air prior to introduction into the eye. In order to humidify the air, 1 cc of balanced salt solution (BSS) is injected into the injection port on the humidifying filter prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
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.
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.
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
§ 886.4360 Ocular surgery irrigation device.
(a)
Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
0
P.02
K974561
Image /page/0/Picture/2 description: The image shows a logo with the letter "A" in a white square on the left. To the right of the square is a black rectangle with several vertical white lines. To the right of the black rectangle is the text "AMERICAN MEDICAL DEVICES, Inc." The text is stacked vertically, with "AMERICAN" on top, followed by "MEDICAL", and then "DEVICES, Inc."
FEB 1 9 1998
1100 Northside Drive Atlanta, Georgia 30318
(Revised) February 12, 1998
Premarket Notification [510(k)] Summary
Submitter: American Medical Devices, Inc 1100 Northside Drive Atlanta, GA 303 18 Phone: (404) 815-5233 (404) 815-5235 Fax:
Official Correspondent: Frank J. Tighe
Trade Name: The American Medical Devices, Inc., Moistair™ Pluid/Air Tubing Set.
Common Name: Fluid/Air Tubing Set
Registration Number: We have registered but have not received our application back as of this date.
Class: Class II
Class Name/Number: 880.5725
Panel: Ophthalmic
Product Code: FRN
Device Description: During a vitrectorny, it is necessary to irrigate balanced salt solution (BSS) into the eye to replace the natural vitreous. If a retinal hole is present, the surgeon must then replace the balanced salt solution (BSS) with air to prevent the fluid from remaining under the retina. One of the problems associated with fluid/air exchange is development of cataracts. The Moistair™ Tubing Set humidifies the dry air prior to introduction into the eye. In order to humidify the air, 1 cc of balanced salt solution (BSS) is injected into the injection port on the humidifying filter prior to use.
Page 1 Summ
| Toll-Free | Direct | Facsimile | Internet |
|---|---|---|---|
| 800-793-1473 | 404-815-5233 | 404-815-5235 | ftighe@americanmedicaldevices.com |
1
Statement of indications for use. - For infusion of fluid and air during vitrectomy
Substantial Equivalence Comparison
| | American Medical
Devices, Inc. | Grieshaber & Co. |
|----------------------------------------------------------------------|-----------------------------------|------------------|
| Packaging
Tyvek to Poly | X | X |
| For infusion of fluid and
Air during vitrectomy | X | X |
| Materials: PVC Tubing Line, .22 micron
Filter, Stopcock, IV Spike | X | X |
| Sterilization ETO | X | X |
| Humidifying Filter | X | X |
Sterility
The Device will be ETO Sterilized.
The method used to validate the sterilization cycle is AAMI Overkill Method
Packaging Material: Tyvek Pouch with a Ploymylar Sheath.
The SAL is 10 to the -6.
The maximum levels of residues of ethylene oxide: 25 parts per million; ethylene chlorohydrin: 25 parts per million and ethylene glycol: 250 parts per million.
This device is non-pyrogenic and the LAL Method is used to make that determination.
Pyrogens: We control the manufacturing environment to lessen the likelihood of pyrogen causing bacteria. In addition the LAL Method is used to determine that each lot is non-pyrogenic.
Materials Use In Manufacture: PVC Tubing, .22 Micron Millipore Filter, PVC 3way stopcock, Plastic Drip Chamber, Plastic Humidifying Filter.
2
Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
FEB 1 9 1998
Mr. Frank J. Tighe Offical Correspondent American Medical Devices, Inc. 1100 Northside Drive Atlanta, GA 30318
Re: K974561 Trade Name: Moistair ™ Fluid Air Tubing Set Regulatory Class: II Product Code: 80 FRN Dated: December 3, 1997 Received: December 5, 1997
Dear Mr. Tighe:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Frank J. Tighe
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page_1_of_1
51D(k) Number (if known): __ K974561
Moistair Fluid Air Tubing Set Device Name:_
Indications For Use:
For infusion of fluid and air during vitrectomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) |
Division of Ophthalmic Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use_ (Per 21 CFR 801.109)
: 上
. . . . .
(
OR
Over-The-Counter Use____
(Optional Format 1-2-16)