(28 days)
MyoSure™ Single Use Seals are a component / accessory to the MyoSURE™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.
The MyoSure™ Rod Lens Hysteroscope incorporates a 3 mm ID working channel and a proximal seal. Additionally, the MyoSure™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD outflow channel which also includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes.
MyoSure™ Rod Lens Scope Seals are comprised of white-tinted silicone.
The provided text is for a 510(k) Pre-market Notification for a medical device called "MyoSure™ Single Use Seals". This type of document is used to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, and thus does not require a full Pre-Market Approval (PMA).
The key takeaway from this document is that the study performed here is NOT a study to prove a device meets acceptance criteria in the sense of demonstrating a certain level of clinical performance (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it's a demonstration of substantial equivalence based on material, dimensional, and functional similarity to a previously cleared device.
Therefore, many of the questions asked in the prompt are not applicable to the type of information presented in this 510(k) submission.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1) | Meets the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices. |
| Bench Test Performance | Meets bench test performance requirements established by Interlace Medical, Inc. (Specific criteria are not detailed in this summary, but assumed to be related to preventing fluid leakage, which is its intended use). |
| Material (Silicone) | The modified seals are fabricated from silicone, equivalent to the predicate seals. |
| Dimensional Identity | The modified seals are dimensionally identical to the predicate seals. |
| Sterility Requirement | All seals are required to be sterile prior to being placed in the MyoSure™ Rod Lens Hysteroscope and outflow channel (implies that the seals themselves are sterile or sterilized before use, but doesn't specify if this is an "acceptance criteria" for the material of the seal itself). |
| Prevent Fluid Leakage (Intended Use) | Demonstrated to be equivalent in functional performance to the predicate seals, which are used to prevent distension fluid leakage. |
Study Details (Based on the provided 510(k) summary, which is a regulatory submission, not a detailed clinical study report)
-
Sample size used for the test set and the data provenance:
- The document implies bench testing was performed. Specific sample sizes for bench testing are not provided.
- Data Provenance: Not explicitly stated as "country of origin." The company is Interlace Medical Inc., located in Framingham, MA, USA. The testing would have been conducted by them or a contracted laboratory. The testing appears to be retrospective in the sense that it's comparing a modified device to a previously approved predicate, but the bench tests themselves would be specific to the modified device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission describes bench testing and a comparison to a predicate device, not a study evaluating human interpretation or clinical outcomes against a defined ground truth established by experts.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is mentioned as this is not a study assessing human reader performance.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device (seals for a hysteroscope), not an AI diagnostic tool. Therefore, an MRMC study is not relevant or described.
-
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This device is a physical component (seals). It does not involve an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Test Performance Requirements: The "ground truth" for the performance testing would be the pre-defined engineering specifications and performance limits for preventing fluid leakage, dimensional accuracy, and biocompatibility, as established by Interlace Medical, Inc. and relevant standards (ISO 10993-1). There is no "clinical ground truth" in the sense of pathology or outcomes.
-
The sample size for the training set:
- Not applicable. This is not an AI/algorithm development, so there's no "training set."
-
How the ground truth for the training set was established:
- Not applicable. (See point 7).
In summary, the K102686 submission is a 510(k) pre-market notification for a minor modification (seals) to an existing hysteroscope. The "study" described is primarily bench testing and a comparison of characteristics to demonstrate substantial equivalence to a predicate device, not a clinical trial or performance study against a complex ground truth involving human experts or AI algorithms.
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Interlace Medical Inc.
K102686
pg. 1 of 2
510(k) SUMMARY 5.
-
- Submitter:
Interlace Medical Inc. 135 Newbury St Framingham, MA 01701 Telephone: 508.875.1343, ext. 112
- Submitter:
Contact: John J. Vozella, VP Clinical & Regulatory Affairs Date Prepared: September 14, 2010
2. Device:
Trade Name: MyoSure™ Single Use Seals Common Name: Hysteroscope and accessories Classification Name: Hysteroscope and accessories Class: II
3. Predicate Device:
MyoSure™ Rod Lens Hysteroscope and Accessories (K091465)
4. Device Description:
The MyoSure™ Rod Lens Hysteroscope incorporates a 3 mm ID working channel and a proximal seal. Additionally, the MyoSure™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD outflow channel which also includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes.
MyoSure™ Rod Lens Scope Seals are comprised of white-tinted silicone.
5. Intended Use:
MyoSure™ Single Use Seals are a component / accessory to the MyoSure™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.
OCT 1 5 2010
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Premarket Notification
K102686
PG: 2 of 2
Comparison of Characteristics: 6.
The design, principles of operation, primary functional specifications and materials of composition of the modified MyoSure™ Single Use Seals are equivalent to those of the predicate scope seals described in the MyoSure™ Rod Lens Hysteroscope (K091465) submission in that:
- all seals are fabricated from silicone, ●
- all seals are dimensionally identical, .
- all seals are required to be sterile prior to being placed in the . MyoSure™ Rod Lens Hysteroscope and outflow channel,
The modified MyoSure™ Single Use Seals' intended use is identical to that of the predicate scope seals (K091465).
7. Performance Testing:
The modified MyoSure™ Single Use Seals meet the biocompatibility requirements .
of ISO 10002, 1 Rialacio d Engle Children of Seat of ISO 10993-1 Biological Evaluation of Medical Devices as well as bench test performance requirements established by Interlace Medical, Inc.
8. Conclusion:
Based on the intended use, descriptive information and performance evaluation provided in this submission, the modified MyoSure™ Single Use Seals have been shown to be equivalent in technology, method of operation, functional performance and intended use to the previously referenced predicate seals.
5-2
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002.
Mr. John Vozella V.P. Clinical and Regulatory Affairs Interlace Medical, Inc. 135 Newbury Street FRAMINGHAM MA 01701
i 5 c.v.h
Re: K102686
Trade Name: MyoSURETM Single Use Seals Regulation Number: 21 CFR $884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: September 14, 2010 Received: September 17, 2010
Dear Mr. Vozella:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related
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adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Interlace Medical Inc.
Premarket Notification
4. INDICATIONS FOR USE STATEMENT
OCT 1 5 2010
510(k) Number (if known): KID2696
Device Name: MyoSure™ Single Use Seals
Indications For Use:
MyoSure™ Single Use Seals are a component / accessory to the MyoSURE™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
510(k) Number .
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)
| (Division Sign-Off) |
|---|
| Division of Reproductive, Gastro-Renal, and Urological Devices |
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§ 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.