(175 days)
Not Found
No
The description focuses on mechanical resection and electrical safety standards, with no mention of AI, ML, or related concepts.
Yes
The device is described as being used to "resect and remove endometrial tissue," which is a direct treatment of a medical condition (submucous myomas and endometrial polyps).
No
Explanation: The device is described as a "Morcellation System" used for surgical resection and removal of endometrial tissue (submucous myomas and endometrial polyps), which is a treatment function, not a diagnostic one.
No
The device description explicitly lists hardware components: a motor drive unit and a motor drive control unit.
Based on the provided information, the Smith & Nephew IUR Morcellation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "resect and remove endometrial tissue" during gynecological procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details a system for mechanical resection and removal of tissue. This is a physical intervention, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples outside the body).
- Providing diagnostic information about a patient's condition based on sample analysis.
- Using reagents or assays.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Smith & Nephew IUR Morcellation System is a surgical tool used for tissue removal in vivo.
N/A
Intended Use / Indications for Use
The Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures by trained professional gynocologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
Product codes (comma separated list FDA assigned to the subject device)
85 HIH
Device Description
The Smith & Nephew IUR Morcellation System is used to perform hysteroscopic surgery for the removal of Submucous myomas and endemontar peopator, a motor drive unit, and a motor drive control unit. Smith & Nephew's IUR Morcellation System uses mechanical resection to remove endometrial polyps and submucous myomas. The Smith & Nephew IUR Morcellation control unit meets UL 2601-1 and IEC 60601-1, electrical safety standards for BF type equipment.
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
gynecological procedures by trained professional gynocologists
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
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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 § 884.9.
0
DEC = 2 2003
Ko3/787
Endoscopy Division
Smith & Nephew, Inc. 150 Minuteman Road, Andover, MA 01810-1031 U.S.A. Telephone: 978-749-1000 Fax: 978-749-1599
Smith+Nephew
510(k) Summary Smith & Nephew IUR Morcellation System Date Prepared: June 9, 2003
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.
Submitter's Name A.
Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, MA 01810
Company Contact B.
Janice Haselton Regulatory Affairs Specialist II Phone: (978) 749-1494 (978) 749-1443 Fax:
Device Name j
| Trade Name: | Smith & Nephew IUR Morcellation System |
|---|---|
| Common Name: | Mechanical Tissue Resection System |
| Classification Name: | Hysteroscopes and Accessories |
Predicate Devices D.
The Smith & Nephew IUR Morcellation System is substantially equivalent in intended use and fundamental The Smith & Nephon TOTC Horomanen of Junarketed device in commercial distribution. FemRx™ Focused Scientific to the Star System, K964441. The materials of construction and design are similar to the Monopolal (1 MI) K953695 and Smith & Nephew Dyonics Power Control Unit, K954989
Description of Device E.
The Smith & Nephew IUR Morcellation System is used to perform hysteroscopic surgery for the removal of I he smilli & Nephow LDI Horocalists of a ... This system incorporates the use of an operative channel Submucous myomas and endemontar peopator, a motor drive unit, and a motor drive control unit. Smith &
Smith+Nephew IUR Morcellation System Page 22 of 211
1
Nephew's IUR Morcellation System uses mechanical resection to remove endometrial polyps and submucous myomas. The Smith & Nephew IUR Morcellation control unit meets UL 2601-1 and IEC 60601-1, electrical safety standards for BF type equipment.
D. Intended Use
The Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures by trained professional gynocologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
Comparison of Technological Characteristics E.
The Smith & Nephew IUR Morcellation System is substantially equivalent in design, materials of construction, function and/or intended use to the following devices cleared for commercial distribution: FemRx™ Focused Monopolar (FMP) 9002 Star System, K964441 Smith & Nephew Dyonics Disposable Arthroscopic Blades, K953695 Smith & Nephew Dyonics Power Control Unit, K954989
Jann Haselton
Janice Haselton Regulatory Affairs Specialist II
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 2003
Ms. Janice Haselton Regulatory Affairs Specialist Endoscopy Smith & Nephew, Inc. 150 Minuteman Road ANDOVER MA 01810
Re: K031787
Trade/Device Name: The Smith & Nephew IUR Morcellation System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: 85 HIH Dated: September 24, 2003 Received: September 25, 2003
Dear Ms. Haselton:
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, 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 (PMA), 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 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.
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office 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 by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division 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,
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
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __ The Smith & Nephew IUR Morcellation System
Indications For Use:
The Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures I he Ghian & Replies - Norocologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| OR | Over-The-Counter Use ______ |
Prescription Use
OR
Over-The-Cou
(Per 21 CFR 801.109)
(Division Sign-Off)
Division Sign-Off) ivision of Reproductive, Abdominal,
510(k) Number
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