(44 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, describing a suction wand for fluid removal. There is no mention of any computational or analytical capabilities that would suggest AI/ML.
No
The device is described as a suction wand designed to remove excess fluid from the surgical field, which is a supportive function during surgery, not a direct treatment or therapy for a disease or condition.
No
The device is described as a "Suction Wand" designed to remove excess fluid from the surgical field, indicating a therapeutic or procedural function rather than a diagnostic one.
No
The device description clearly outlines physical components made of stainless steel and ABS, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is designed and indicated for removing excess fluid from the surgical field. This is a direct interaction with the patient's body during a surgical procedure, not an analysis of samples taken from the body.
- Device Description: The description details a physical suction wand used for fluid removal during surgery. There is no mention of analyzing biological samples or performing tests on them.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Using reagents or test kits
In summary, the device's function is to physically remove fluid during surgery, which falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field.
Product codes
DTS
Device Description
The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field. The Standard Rigid Tip Suction Wand consists of an angled Stainless Steel suction wand bonded to a rigid, fluted style suction tip at the distal end and a ¼" barbed connector at the proximal end both of which are made of ABS. The stainless steel wand has a lightweight plastic handle made of medical grade ABS material. The Small Rigid Tip Suction Wand is manufactured in a similar manner and consisting of the same materials as the Standard Rigid Tip Suction Wand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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
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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.
Research Medical, Inc. Rigid Intracardiac Suction Wand
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
Not Found
§ 870.4420 Cardiopulmonary bypass cardiotomy return sucker.
(a)
Identification. A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass 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 § 870.9.
0
K982841
Summary of Safety and Effectiveness
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The California Medical Laboratories. Inc. devices are substantially equivalent to the Research Medical predicate device. The California Medical Laboratories, Inc. devices have substantially equivalent intended uses as the predicate device. The California Medical Laboratories, Inc. devices have technologic characteristics, which are substantially equivalent to the Research Medical predicate device.
COMPANY AND CONTACT PERSON
California Medical Laboratories Inc. 2681 Kelvin Avenue Irvine, California 92614
Mehmet Bicakci President
DEVICE NAME
California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wand
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
The claim of substantial equivalence is based upon the following device:
- Research Medical, Inc. Rigid Intracardiac Suction Wand .
DESCRIPTION OF DEVICE
The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field.
The Standard Rigid Tip Suction Wand consists of an angled Stainless Steel suction wand bonded to a rigid, fluted style suction tip at the distal end and a ¼" barbed connector at the proximal end both of which are made of ABS. The stainless steel wand has a lightweight plastic handle made of medical grade ABS material.
The Small Rigid Tip Suction Wand is manufactured in a similar manner and consisting of the same materials as the Standard Rigid Tip Suction Wand.
STATEMENT OF INTENDED USE
The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field.
STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES
The predicate device has the same intended use as stated above.
STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE
The California Medical Laboratories, Inc devices have technologic characteristics, which are substantially equivalent to the predicate device.
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUM SERVICES USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Mr. Mehmet Bicakci President California Medical Laboratories, Inc. 2681 Kelvin Avenue Irvine, California 92614
Re: K982891 Trade Name: California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wand Regulatory Class: II Product Code: DTS Dated: August 14, 1998 Received: August 17, 1998
Dear Mr. Bicakci:
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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set torth 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 requlatory 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 - Mr. Mehmet Bicakci
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 leqally 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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
3
510(k) Number (if known):
California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Device Name: Wands
Indications
For Use:
The Standard and Small Rigid Tip Suction Wands are indicated for use to remove excess fluid from the surgical field.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K982891
Prescription Use
Per 21 CFR 801.109
Over-The-Counter Use _ OR
(Division Sign-Off)
Division of General Restorative Devices
(reg.) Number 15982891
'
510(k) Number
510(k) Notification California Medical Laboratories, Inc. CONFIDENTIAL 8/9/1998