(111 days)
No
The summary describes a mechanical morcellation system with a control unit, handpiece, and footswitch. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on electrical safety, EMC, and in-vitro comparison to a predicate device, not on algorithmic performance.
Yes
The device is intended to resect and remove tissue, which aligns with the definition of a therapeutic intervention.
No
Explanation: The device description states its purpose is to "resect and remove tissue," indicating a therapeutic rather than diagnostic function. It is used for intrauterine procedures, not for identifying or diagnosing conditions.
No
The device description explicitly lists hardware components such as a Control Unit, Morcellator Handpiece, Single Use Morcellator, and Footswitch.
Based on the provided information, the Interlace Medical Hysteroscopic Morcellation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "hysteroscopic intrauterine procedures... to resect and remove tissue". This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample of tissue or fluid outside the body.
- Device Description: The components listed (Control Unit, Handpiece, Morcellator, Footswitch) are consistent with a surgical device used for tissue removal, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any features related to analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device is used to remove tissue from the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Interlace Medical Hysteroscopic Morcellation System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
Product codes
HIH
Device Description
The system consists of the following components:
- Control Unit
- Morcellator Handpiece
- Single Use Morcellator
- Footswitch
The Interlace Medical Hysteroscopic Morcellation System will be used with standard hysteroscopes and fluid management systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained gynecologist
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)
The Interlace Medical Hysteroscopic Morcellation System meets electrical safety and EMC standards. In addition, an in-vitro test was conducted which demonstrated that the device performs equivalent to or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Smith and Nephew Hysteroscopic Morcellation System K041774
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.
0
Interlace Medical Inc. Hysteroscopic Morcellation System Premarket Notification
Interlace Medical Hysteroscopic Morcellation System 510K Summary of Safety and Effectiveness April 11, 2008
APR 1 7 2008
- Sponsor Name Sponsor/Manufacturer Interlace Medical Inc. 139 Newbury St Framingham, MA 01701 Telephone: 508.875.1343
-
- Device Name Proprietary Name: Interlace Medical Hysteroscopic Morcellation System Common/Usual Name: Hysteroscope and accessories
- Identification of Predicate or Legally Marketed Device 3. The Interlace Medical Hysteroscopic Morcellation System is substantially equivalent to the Smith and Nephew Hysteroscopic Morcellation System K041774.
-
- Device Description The system consists of the following components:
- Control Unit o
- Morcellator Handpiece o
- Single Use Morcellator ಂ
- Footswitch O
The Interlace Medical Hysteroscopic Morcellation System will be used with standard hysteroscopes and fluid management systems.
-
- Intended Use
The Interlace Medical Hysteroscopic Morcellation System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
- Intended Use
1
Interlace Medical Inc.
Premarket Notification
Hysteroscopic Morcellation System
- Comparison of Technological Characteristics The principles of operation of the Interlace Medical Hysteroscopic Morcellation System are identical to those of the predicate device, the Smith and Nephew Hysteroscopic Morcellation System K041774. A disposable straight surgical morcellator is inserted into a morcellator handpiece for tissue removal. A footswitch is used to turn the morcellator on and off. The morcellator consists of a rotating and reciprocating inner tube or cutter that is totally contained within an outer tube and has a fitting at its proximal end to which vacuum tubing is attached. The outer tube incorporates a "cutting window" through which targeted tissue is pulled, cut, and moved back through the inner tube to a collection canister.
7 Performance Testing The Interlace Medical Hysteroscopic Morcellation System meets electrical safety and EMC standards. In addition, an in-vitro test was conducted which demonstrated that the device performs equivalent to or better than the predicate device.
8. Statement of Equivalency
The Interlace System is substantially equivalent in design, materials, construction and intended use as that of the predicate. The principal of operation of both devices are exactly the same. Since the Interlace Morcellator has the same in intended use and technological characteristics as the predicate device, the Interlace Morcellator does not raise any new safety and efficacy concerns when compared to the similar legally marketed device.
The descriptive characteristics demonstrate that the Interlace Morcellator is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 7 2008
Mr. Ron Adams Chief Technical Officer Interlace™ Medical 139 Newbury Street FRAMINGHAM MA 01701
Re: K073690
,
Trade/Device Name: Interlace Medical Hysteroscopic Morcellation System Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: March 27, 2008 Received: March 28, 2008
Dear Mr. Adams:
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.
Image /page/2/Picture/10 description: The image is a circular seal with the text "ISOS - 2006" at the top. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. There are three stars below the word "Centennial". The text around the edge of the seal is difficult to read.
3
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. B rogdon 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): K073690
Device Name: Interlace Medical Hysteroscopic Morcellation System
Indications For Use:
The Interlace Medical Hysteroscopic Morcellation System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
Prescription Use X (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)
Judd Lewin
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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _