(33 days)
N/A
N/A
No
The summary describes a gravity-based fluid management system with a hand pump and clamps, with no mention of AI or ML terms, image processing, or performance studies related to algorithmic output.
No
The device is used for fluid management (distention and flushing) during arthroscopic procedures, which are interventional rather than therapeutic. It aids in clearing debris and providing visibility, but does not directly treat a disease or condition. Its predicate device is also an "Irrigation Set".
No
The device is described as a gravity system for fluid management and irrigation during arthroscopic procedures, used to distend the site and clear debris. Its function is therapeutic/supportive (flushing and maintaining visibility) rather than identifying or characterizing a disease or condition. Its predicate device, K883300, is also an irrigation set.
No
The device description clearly states it is a "gravity system for fluid management" and mentions components like a "hand pump" and "click clamps," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fluid management during arthroscopic procedures to distend the site and flush debris. This is a surgical procedure aid, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a gravity system with a hand pump and clamps for controlling fluid flow during surgery. This aligns with a surgical irrigation device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The purpose is purely functional during the surgical procedure.
Therefore, the Tuta Healthcare Pty. Limited Arthroscopy Flushing set is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tuta Healthcare Pty. Limited Arthroscopy Flushing set (80.601) is a gravity system for fluid management during arthroscopic procedures. During these procedures, the fluid is used to (1) distend the site, enabling good visibility and (2) flush it continuously to clear debris (loose bodies or cartilage fragments away).
Device Description
The Tuta Healthcare Arthroscopy Flushing set is designed to provide controlled Irrigation to a joint during arthroscopic procedures. action of the hand pump help to remove blood, tissue debris, loose bodies and foreign matter from the joint cavity. The click clamps are used to block the flow of fluid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
joint
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) (K number(s) and name(s); separate multiples with ";")
K883300 - Irrigation Set - Edwards Orthopedic Division, Baxter Healthcare
Reference Device(s) (K number(s) and name(s); separate multiples with ";")
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
510 (k) Summary
Summary of Safety and Effectiveness for Tuta's Arthroscopic Flushing Device.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Assigned 510(k) number K 020003
| 1. Manufacturer's Name: | Tuta Healthcare Pty. Limited | |
|---|---|---|
| Manufacturer's Address | 318-332 Burnsbay Road | |
| Lane Cove , Sydney NSW 2066 | ||
| Australia | ||
| Contact Person: | Omid Souresrafil PhD | |
| Telephone Number: | + 61 2 94270300 (Switchboard) |
- 61 2 9429 6381 (Direct) |
| | Fax Number: | +61 2 9427 5017 |
| | Date: | 24/12/01 |
| | 2. Device Name:
Trade Name:
Proprietary Name:
Classification Name: | Arthroscopy Flushing Set
Tuta Healthcare Arthroscopy Flushing Set 80.60
Arthroscope Accessory (per 21CFR 888.1100) |
3. Legally Marketed Equivalent Device
Irrigation Set (K883300) - Edwards Orthopedic Division, Baxter Healthcare
The. Arthroscopy Flushing set in the submission is substantially equivalent to Edwards Orthopaedic Division (K883300), Baxter Healthcare Irrigation - Set
The Arthroscopy flushing set and the Edwards Orthopaedic Division devices are designed to provide irrigation, better visualization for the cleansing of surgical sights .
4. Description of the intended use of the Device
The Tuta Healthcare Arthroscopy Flushing set is designed to provide controlled Irrigation to a joint during arthroscopic procedures. action of the hand pump help to remove blood, tissue debris, loose bodies and foreign matter from the joint cavity. The click clamps are used to block the flow of fluid.
-
- Distend the arthroscopy sight enabling good visibility and
-
- Flush the sight continuously to clear debris (loose bodies or cartilage fragments) away.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2002
Omid Souresrafil, Ph.D. Onlid Bouretirence and Regulatory Affairs Manager Tuta Healthcare Pty. Limited 318-332 Burns Bay Road Lane Cove NSW 2066 Australia
Re: K020083
Trade/Device Name: Arthroscopy Flushing Set Regulation Number: 881.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: January 8, 2002 Received: January 10, 2002
Dear Dr. Souresrafil:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 210(x) prematics is substantially equivalent (for the indications
referenced above and have determined the device and designs marketed in inters referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device. Device Amendments for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food Drug. commerce prior to May 28, 1970, the chacultions of the Federal Food, Drug, devices that have been reculted in accordance while as proval application (PMA).
and Cosmetic Act (Act) that do not require approval assured approval applicions of the Act . and Cosmetic Act (Act) that to not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the generats for annual registration, listing of
general controls provisions of the Act include required it it is and includ general controls provisions of the Fectificate required in the believe against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mits existing major regulations affecting your device can
may be subject to such additional controls. Title may be subject to such additional controlis: Lincting includes be found in the Code of Poderal Regaring your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a succession of the requirements of the Act
that FDA has made a determination that your device complies with onemal that FDA has made a decertimation that your assessment of the Federal agencies. You must and listing or any Federal statutes and regulations daminding, but not limited to registration and listing (21
comply with all the Act's requirements, including, but not researces set comply with all the Act 3 requirements, mercessed in and in the requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFK Part 807); labeling (21 CFR Part 800); god analifant 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QD) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
2
Page 2 - Omid Souresrafil, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will anow yourse ought miling of substantial equivalence of your device to a legally premaired 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 11 you doolly 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Cr 11 cm 11 cm . 4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 + 10th Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O wision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
4. STATEMENT OF INDICTIONS FOR USE
510(k) Number (if known): _ K 02008 3
Device Name: Arhtroscopy Flushing Set
Indications For Use:
The Tuta Healthcare Pty. Limited Arthroscopy Flushing set (80.601) is a gravity system Prescription Use (X), (Per 21 CFR 801.109 for fluid management during arthroscopic procedures. During these procedures, the fluid is used to (1) distend the site, enabling good visibility and (2) flush it continuously to clear debris (loose bodies or cartilage fragments away).
iriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_KO20083
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (X) (Per 21 CFR 801.109)
510 (k) Application -- Arthroscopy Flushing Set Tuta Healthcare Pty. Limited