(25 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical fluid evacuation and do not mention any AI/ML components or functionalities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is used to remove excess irrigation fluids during microscopic eye surgery, which is a supportive function rather than directly treating a medical condition or restoring a bodily function.
No
The purpose of the device is to remove excess irrigation fluids, not to diagnose a condition or disease.
No
The device description clearly outlines physical components such as a sponge tip, stainless steel cannula, suction tubing, and adapter, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Sof-Suction™ Fluid Evacuation System is used to remove excess irrigation fluids during microscopic eye surgery. It's a surgical tool used directly on the patient during a procedure, not for analyzing samples in vitro (outside the body).
The description clearly indicates its function is to manage fluids during surgery, which is a therapeutic/surgical application, not a diagnostic one.
N/A
Intended Use / Indications for Use
The device is used to continuously wick away irrigation fluid during eye surgery in an atraumatic manner since the suction does not reach the delicate tissues of the eye. The device can also be used in neurosurgery and other surgeries that cannot tolerate direct suction on tissue.
The Sof-Suction™ Fluid Evacuation System is used to remove excess irrigation fluids The Bot-Baction - Pland 24 assumed aring microscopic eye surgery to mitigate the effects n of the medial cannies of the eye aid as a see and to prevent stagnant irrigating fluid from entering the eye
Product codes (comma separated list FDA assigned to the subject device)
86 HOZ
Device Description
Consists of a proximal portion consisting of a 11 mm x 7 mm x 7 mm polyvinyl acetal sponge tip fastened by heat bonding to a 7 mm 18Ga thin wall 301 stainless steel cannula friction attached to a 36'' 5 Fr polyvinyl acetate suction tubing, attached with medical grade adhesive to a ¼" standard suction tubing adapter. Included with the device is adhesive tape for fixating the suction tubing.
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
§ 886.4790 Ophthalmic sponge.
(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(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 the limitations in § 886.9.
0
4/2/99
X-TECH® MEDICAL
K9907499
510(k) Summary
Date of Application: March 4, 1999
| Applicant: | X-TECH® Medical |
|---|---|
| 111 Wild Oak Court | |
| Danville, CA 94506 | |
| Contact Person: | Edgar A. Rainin, MD, President |
| Phone: | 925-736-5001 |
| Fax: | 925-736-8315 |
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- TRADE NAME: SOF-SUCTION™ FLUID EVACUATION SYSTEM
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- COMMON NAMES: eye spears, sponge points & suction tubing
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- CLASSIFICATION NAME: sponge, ophthalmic & tube, aspirating, flexible, connecting
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- EQUIVALENT TO: Merocel Sponge Points and Datex-Ohmeda Suction Tubing.
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- DESCRIPTION OF DEVICE: Consists of a proximal portion consisting of a 11 mm x 7 mm x 7 mm polyvinyl acetal sponge tip fastened by heat bonding to a 7 mm 18Ga thin wall 301 stainless steel cannula friction attached to a 36'' 5 Fr polyvinyl acetate suction tubing, attached with medical grade adhesive to a ¼" standard suction tubing adapter. Included with the device is adhesive tape for fixating the suction tubing.
-
- INTENDED USE: The device is used to continuously wick away irrigation fluid during eye surgery in an atraumatic manner since the suction does not reach the delicate tissues of the eye. The device can also be used in neurosurgery and other surgeries that cannot tolerate direct suction on tissue.
-
- TECHNOLOGICAL CHARACTERISTICS: Our device consists of a combination of the Merocel Sponge Point and Suction Tubing. This results in continuous wicking by the sponge since the sponge is continuously emptied at its distal reservoir by aspirating the fluid from the reservoir. We are introducing no new materials. We are simply combining two proven technologies in a new, safe and effective manner.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1099
Edgar A. Rainin, MD President X-TECH®MEDICAL 111 Wild Oak Court Danville, CA 94506
Re: K990749 Trade Name: Sof-Suction Fluid Evacuation System Regulatory Class: II Product Code: 86 HOZ Dated: March 4, 1999 Received: March 8, 1999
Dear Dr. Rainin:
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 .
2
Page 2 - Edgar A. Rainin, MD
ﺪ
· This letter will allow you to begin marketing your device as described in your 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 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 device, 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 Roerl. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health .......
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Page 2a of 3
510(k) Number: K 990749
Device Name: Sof-Suction™ Fluid Evacuation System
Indications For Use:
The Sof-Suction™ Fluid Evacuation System is used to remove excess irrigation fluids The Bot-Baction - Pland 24 assumed aring microscopic eye surgery to mitigate the effects n of the medial cannies of the eye aid as a see and to prevent stagnant irrigating fluid from entering the eye
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurel W.C. Brown, Ph.D
(Division Sign Off)
js
sion Sion-C ivision of Ophthalmic D 510(k) Number.
Prescription Use_v (Per 21 CFR 801.109).