(98 days)
No
The document describes a mechanical device with a reciprocating cutting mechanism and does not mention any AI/ML terms or functionalities.
No
The device is described as a morcellation system used to resect and remove tissue, which is a surgical tool, not a therapeutic device designed to treat a condition.
No
The device is described as a morcellation system used to resect and remove tissue, not to diagnose conditions. Its intended use is for surgical intervention, not for identifying or characterizing diseases.
No
The device description clearly describes a physical, disposable, sterile, reciprocating morcellator with cutting mechanisms, indicating it is a hardware device, not software only.
Based on the provided information, the Smith & Nephew IUR Morcellation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "resect and remove endometrial tissue" from the uterus during gynecological procedures. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is a "reciprocating morcellator" used to "remove submucous myomas and endometrial polyps from the uterus." This describes a surgical tool for tissue removal.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical tissue removal.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
Product codes
85 HIH
Device Description
The IUR Reciprocating Morcellator is a disposable, sterile, reciprocating morcellator used in conjunction with the currently cleared Smith & Nephew IUR Morcellation System (K031787), to remove submucous myomas and endometrial polyps from the uterus. The reciprocating design utilizes both a rotational and reciprocating cutting mechanisms. The predicate design utilizes a rotational cutting mechanism only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional gynecologists
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)
In vitro testing of the IUR Reciprocating Morcellator demonstrates that the addition of new materials and the proposed design modifications does not impact the safety and performance of the proposed device.
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
§ 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.
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K041774
Page 1 of 2
SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew IUR Reciprocating Morcellator
Date Prepared: June 30, 2004
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Janice Haselton Regulatory Affairs Specialist (978) 749-1494 Phone: (978) 749-1443 Fax:
C. Device Name
| Trade Name: | Smith & Nephew IUR Reciprocating Morcellato |
|---|---|
| Common Name: | Hysteroscopic Morcellator |
| Classification Name: | Hysteroscopes and Accessories |
D. Predicate Devices
The Smith & Nephew Smith & Nephew IUR Reciprocating Morcellator is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution Smith & Nephew IUR Morcellator cleared in K031787.
Description of Device E.
The IUR Reciprocating Morcellator is a disposable, sterile, reciprocating morcellator used in conjunction with the currently cleared Smith & Nephew IUR Morcellation
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K041774
Page 2 of 2
System (K031787), to remove submucous myomas and endometrial polyps from the uterus. The reciprocating design utilizes both a rotational and reciprocating cutting mechanisms. The predicate design utilizes a rotational cutting mechanism only.
F. Intended Use
The Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
G. Comparison of Technological Characteristics
Both the proposed IUR Reciprocating Morcellator and the predicate IUR Rotary Morcellator, cleared in K031787, are substantially equivalent in intended use, materials and overall design dimensions. Both devices snap and lock in place into the motor drive unit of the IUR Morcellation control unit, via a latch mechanism on the outer adapter body. Based on these similarities Smith & Nephew believes that the IUR Reciprocating Morcellator is substantially equivalent to the predicate device currently on the market.
H. Summary Performance Data
In vitro testing of the IUR Reciprocating Morcellator demonstrates that the addition of new materials and the proposed design modifications does not impact the safety and performance of the proposed device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2004
Ms. Janice Haselton Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road ANDOVER MA 01810
Re: K041774
Trade/Device Name: IUR Reciprocating Morcellator Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: 85 HIH Dated: September 10, 2004 Received: September 13, 2004
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 (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 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) I his letter will and in your is organization of substantial equivalence of your device to a legally premaince notification - 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 rryou debire openite at none of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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: _Smith & Nephew IUR Reciprocating Morcellator ___________________________________________________________________________________________________________________
KOYITY
Indications For Use:
The Smith & Nephew IUR Morcellation System is intended for use in gynecological The Simm & Nephew York Horeenance " "Jocologists to resect and remove endometrial tissue procedures by trained promotions, submucous myomas and endometrial polyps.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801 Subpart D)
(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)
| (Division Sign-Off) |
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K041774 |
|---|---|
| --------------- | --------- |
Smith
IURith & Nephew, Inc R Reciprocating Morcellator Page 15 of 5