(115 days)
Not Found
No
The description focuses on mechanical components and controlled powered irrigation, with no mention of AI, ML, image processing, or data-driven decision making.
No.
The device provides controlled powered irrigation during laparoscopic surgical procedures, which is a supportive function rather than directly treating a disease or condition.
No
The device is described as providing controlled powered irrigation during laparoscopic surgical procedures, and for resection of adhesions and peritoneal lavage. These are therapeutic or operative functions, not diagnostic ones.
No
The device description explicitly lists hardware components such as a Disposable Pump Head, pump motor, clamp & bracket, power supply, and power cord, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing controlled powered irrigation during laparoscopic surgical procedures. This is a surgical tool used in vivo (within the body) during a procedure, not for testing samples in vitro (outside the body).
- Device Description: The device components are described as a pump head, motor, clamp, power supply, and tubing, all designed for delivering fluid during surgery. There is no mention of reagents, assays, or any components typically associated with diagnostic testing of biological samples.
- Lack of IVD Keywords: The document does not contain any keywords or phrases commonly associated with IVD devices, such as "diagnostic," "assay," "sample," "analyte," "laboratory," etc.
- Predicate Device: The listed predicate device (K961492 Davol (Bard)) is also likely a surgical irrigation device, further supporting the conclusion that this is not an IVD.
In summary, the device's function and description align with a surgical instrument used during a procedure, not a device used for diagnosing conditions by testing samples outside the body.
N/A
Intended Use / Indications for Use
The “candidate device” is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures.
The "candidate device" is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.
The MultApump™ System is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures.
Product codes
GCJ
Device Description
The “candidate device” consists of a Disposable Pump Head, pump motor, clamp & bracket, power supply and power cord(s) for use in laparoscopy. The Disposable Pump Head is a sterile, single-use device, composed of Stainless Steel, glass filled Polypropylene, Medical Grade EPDM, ABS plastic, plastic and flexible PVC tubing. It has an interface dock for attachments of the reusable pump motor. The pump motor, clamp, power supply and power cord are reusable components.
The pump motor, clamp, bracket, power supply and power cord are reusable components. The Disposable Pump is supplied as a sterile, single-use product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
F: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY
| 1) | Submitter: | Dexide, Inc.
7509 Flagstone Drive
Fort Worth, TX 76118-6995
Phone No.: (817) 589-1454 |
|----|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Lynette Caldwell
Director of Quality Assurance |
| | Date Prepared: | Friday, May 29, 1998 |
| 2) | Name of Device: | MultApump™ System |
| | Common Name: | Irrigation Pump |
| 3) | Predicate Device: | Davol (Bard) -K961492 |
| 4) | Description of Device: | The “candidate device” consists of a Disposable Pump
Head, pump motor, clamp & bracket, power supply and
power cord(s) for use in laparoscopy. The Disposable
Pump Head is a sterile, single-use device, composed of
Stainless Steel, glass filled Polypropylene, Medical Grade
EPDM, ABS plastic, plastic and flexible PVC tubing. It has
an interface dock for attachments of the reusable pump
motor. The pump motor, clamp, power supply and power
cord are reusable components. |
| 5) | Intended Use: | The “candidate device” is designed to be used in
conjunction with a laparoscopic irrigation/suction device to
provide controlled powered irrigation during laparoscopic
surgical procedures. |
- Technological characteristics the candidate device is comparable to the predicate device 6) in that both devices provide controlled powered irrigation during laparoscopic surgical procedures.
1
SECTION G:
MANUFACTURER'S STATEMENT OF SUBSTANTIAL EQUIVALENCE
(To be provided with 510(k) notification for tier 2 devices)
STATEMENT OF INDICATIONS FOR USE: The "candidate device" is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.
CLAIMS: The pump motor, clamp, bracket, power supply and power cord are reusable components. The Disposable Pump is supplied as a sterile, single-use product.
This notification contains all of the information required by 21 CFR 807.87. A completed copy of the "DRAERD Premarket Notification 510(k) Reviewer's Screening Checklist" is attached.
The candidate device conforms to the following voluntary and mandatory standards:
There are no existing mandatory performance standards that Dexide, Inc is aware.
The candidate device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of action are equivalent. If the candidate device is a kit, all of the contents of the kit are either pre-Amendment devices or have been cleared for marketing through previous 510(k)'s. The kit contains no drug or biologic products.
The above statements are accurate representations of this 510(k) Premarket Notification and of the device this firm intends to market. All data and information submitted in this Premarket Notification is truthful and accurate and no material fact has been omitted (21 CFR 807.87(J)).
| MANUFACTURER: | Dexide, Inc. | |
|---|---|---|
| OFFICIAL CORRESPONDENT: | Lynette Caldwell | (signature) |
| Lynette Caldwell | (printed name) | |
| TITLE: | Director of Quality Assurance | |
| DATE: | August 4, 1998 |
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three figures in profile, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 1998
Ms. Lynette Caldwell Director of Quality Assurance Dexide, Inc. 7509 Flagstone Drive Fort Worth, TX 76118-6995
K981940 Re: Trade Name: MultApump Disposable Pump Head and Accessories Regulatory Class: II Product Code: GCJ Dated: August 10, 1998 Received: August 21, 1998
Dear Ms. Caldwell:
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 The general controls provisions of the Act 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. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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 - Ms. Lynette Caldwell
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) 594-4595. 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.qov/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
4
| Page | 1 |
|---|---|
| of | 1 |
| 510(k) Number (if known): | K981940 |
|---|---|
| Device Name: | MultApump™ System |
:
Intended Use:
. . . . . .
The MultApump™ System is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures.
(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 General Restorative Devices | K981940 |
| 510(k) Number |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |
(Optional Format 1-2-96) __
OR
Prescription Use
(Per 21 CFR 801.109)