(269 days)
Not Found
No
The summary describes a mechanical device that converts continuous suction to intermittent suction using a cyclical process, with no mention of AI or ML terms, image processing, or data-driven training/testing.
Yes
The device is used for aspiration of gastro-intestinal fluid, which is a medical function, and its intended use is to maintain "continuous suction" on the aspiration tube, making it a therapeutic device.
No
The device is used for aspiration of gastro-intestinal fluid, not for diagnosing a condition. Its function is to manage suction for fluid removal.
No
The description focuses on the mechanical function of converting continuous suction to intermittent suction, implying a hardware component that controls the suction flow. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that manages suction for aspiration of gastro-intestinal fluid from the patient. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes related to fluid management, not for testing samples in vitro (outside the body).
- Device Description (though not found): The description of how it works (converting continuous suction to intermittent suction for aspiration) further supports its function as a medical device used directly on the patient.
- Anatomical Site: The device is used in the "gastro-intestinal tract," which is an anatomical site within the patient's body.
- Predicate Device: The predicate device listed (K951423; Continuous & Programmable Intermittent Aspirator) is also a device used for aspiration, not for in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on specimens.
N/A
Intended Use / Indications for Use
The intended use of the device is to convert regulated continuous suction to "intermittent suction" appropriate for aspiration of gastro-intestinal fluid into two separate chambers that are reversed in on/off phases. This permits gravity "refeeding" of the aspirate during the "off" phases of cach chamber's cycle, while maintaining "continuous suction" on the aspiration tube.
I he proposed device interrupts externally supplied continuous suction to individually provide "intermittent suction" to one or two aspiration catheters positioned in the patient's gastrointesunal tract.
Product codes (comma separated list FDA assigned to the subject device)
KNT, 78 KNT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastro-intestinal tract
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.
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
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
TAB 4. 510(k) SUMMARY INFORMATION
.
| NAME: | Moss Medical Products, Inc. |
|---|---|
| ADDRESS: | 4049 NY 150 |
| West Sand Lake, NY 12196 | |
| PHONE: | 518-674-0904 |
| FAX: | 914-684-1464 |
| E-MAIL: | mosstube@mossmed.com |
| ACTIVITY OF APPLICANT | Initial Distributor |
| CONTACT PERSON: | GERALD MOSS, Ph.D., M.D. |
| ADDRESS: | 1 Reynal Road |
| White Plains, NY 10605 | |
| PHONE: | 914-997-0392 |
| FAX: | 914-684-1464 |
| E-MAIL: | gerald_moss@mossmed.com |
| NAME OF DEVICE | |
| TRADE NAME: | MossMed Dual Intermittent Aspirator |
| COMMON NAME: | Suction Controller |
| CLASSIFICATION NAME: | 21 CFR 878.4780 Powered Suction Pump |
| PRODUCT CODE: | KNT |
| MANUFACTURER: | Hudson Research, Inc. |
| 461 Pinebrook Boulevard | |
| New Rochelle, NY 10804 | |
| PREDICATE DEVICE: | Continuous & Programmable Intermittent Aspirator |
- Impact Instrumentation, Inc. (K951423) |
| INDICATION FOR USE: | The intended use of the device is to convert
regulated continuous suction to "intermittent
suction" appropriate for aspiration of gastro-
intestinal fluid into two separate chambers that are
reversed in on/off phases. This permits gravity
"refeeding" of the aspirate during the "off" phases of
cach chamber's cycle, while maintaining "continuous
suction" on the aspiration tube. |
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2004
Gerald Moss, Ph.D., M.D. President Moss Medical Products, Inc. 4049 NY 150 WEST SAND LAKE NY 12196
Re: K031492
Trade/Device Name: MossMed Dual Intermittent Aspirator Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: November 6, 2003 Received: November 7, 2003
Dear Dr. Moss:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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. Iisting 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough.
premarket notification. The FDA finding of substantial equivalence of your device to a legally prematicated 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), please It you don't specifice of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Other or other to premarket notification" (21CFR Part 807.97) you may obtain. Other general of receise to promise on your responsibilities under the Act may be obtained from the Division of Small imorination on your responsible 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K031492
Device Name:
Moss Medical Products, Inc. Dual Intermittent Aspirator Indications For Use:
I he proposed device interrupts externally supplied continuous suction to individually provide "intermittent suction" to one or two aspiration catheters positioned in the patient's gastrointesunal tract.
Prescription Use:
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Basdon
Page 1 of
(Division Sign-Off Division of Reproductive, Abe and Radiological Devices 510(k) Number